PAGE 1

What You Need To Know About The EUrsquos New Medical Device Regulation MDR amp IVDRAN EBOOK FROM THE ULG LIBRARY

eBooklibrary

PAGE 2

When will the MDR and IVDR take full effect

2020 for the MDR 2022 for the IVDR

Why were the MDR and IVDR enacted and which key areas are changing

The MDR and IVDR replace old directives (9342EEC and

90385ECC) that were established well before the digital

age In addition to bringing the regulatory environment up to

speed on technology theyrsquore designed to pave the way for

better post-market surveillance transparency traceability

innovation and patient safety and outcomes

The new regulations expand the definition of whatrsquos considered

a medical device change some classifications introduce new

labeling requirements and generally seek better information

access for patients regulatory bodies medical practitioners

and members of the public They also create more uniform

enforcement across EU member states and in the words

of the European Council ldquohellip overcome legal gaps thereby

supporting innovation and the competitiveness of the medical

device industryrdquo

Finally with product recalls on the rise and 15 percent caused

by labelling errors (Deloitte) the new regulations seek to

prevent medical device malfunction and misuse caused by

inadequate labeling

Sweeping new regulations in a euro100 billion global market are bound to have an impact The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are certainly no exceptions

These new laws are a big win for patients But for medical device manufacturers they present significant new requirements in labeling and overall product transparency

Here are some of the top questions wersquore hearing about MDR and IVDR and our expert answers

PAGE 3

Whorsquos most affected

The new rules apply not only to medical device manufacturers

across all 28 EU member states but also to non-European companies looking to distribute or market their products inside the EU Unlike previous device directives the MDR and

IVDR are not ldquogeneral guidelinesrdquo In other words individual

EU member states wonrsquot have the flexibility to implement their

own interpretations of each regulation

What are the new labeling requirements

The two most significant changes to labeling in the new

regulations are

1 Device companies must keep device information and

Instructions For Use (IFUs) on their websites and adhere

to specific E-labeling requirements

2 IFUs must be written in terms ldquoreadily understood by

the intended end userrdquo and must contain information

on safety and clinical performance of the device where

applicable

Most of these changes are outlined in the MDR (231) which

states (emphasis added)

Each device shall be accompanied by the information needed to identify

the device and its manufacturer and by any safety and performance

information relevant to the user or any other person as appropriate

Such information may appear on the device itself on the packaging or in

the instructions for use and shall if the manufacturer has a website

be made available and kept up to date on the website taking into

account the following

231(a) the medium format content legibility and location of the

label and instructions for use shall be appropriate to the particular

device its intended purpose and the technical knowledge

experience education or training of the intended user(s) In

particular instructions for use shall be written in terms readily

understood by the intended user and where appropriate

supplemented with drawings and diagrams

The MDR goes on to state in 231(f) that ldquoInstructions for

use may be provided to the user in non-paper format (eg

electronic) to the extent and only under the conditions

set out in Regulation (EU) No 2072012rdquo This regulation

includes full requirements when labeling is provided only

electronically as well as minimum requirements for when

labeling is provided in paper format and on a website

These items present some significant challenges (eg trying

to define ldquoreadily understoodrdquo) But one thing thatrsquos clear

is the need for device-makers to develop more robust systems for label version control risk management and content management across multiple communications platforms Manufacturers should thoroughly review these

new labeling requirements determine what needs to be

changed or updated review their existing documentation

determine where everything is stored and how its integrity is

maintained ensure their labeling information is reliable and

PAGE 4

accurate and implement a content management system

that includes a revisions strategy

Whatrsquos most important about the new UDI requirements

In their effort to reduce errors improve public data access

and fight fraud the MDR and IVDR stress the importance

of monitoring medical devices throughout their lifetimes As

part of that the new regulations require that products contain

a Unique Device Identification (UDI) in addition to other

required labeling The UDI includes a Device Identifier (DI) a

Product Identifier (PI) the risk class of the device the device status (recall information summary of safety and performance

for class C or D devices) and if applicable additional product descriptions storage andor handling conditions

Placed on devices or their packaging UDIs will contain

barcodes that can be scanned to retrieve information via

EUDAMED the developing online information portal that

will include data on the devicersquos purpose description risks

warnings and precautions EUDAMED is accessible to patients

as well as the general public so all information within it

needs to be written in a way thatrsquos easily understandable for

average users not just people in the medical industry UDI

information needs to be tracked by manufacturers importers

distributors and in some cases healthcare professionals And

new UDIs are required whenever a device changes in a way

that confuses its traceability

The new UDI system impacts how you create tag and

store data You need to make sure that UDI terminology is

consistent and that correct labeling procedures are followed

so the information is usable within both EU and US systems

As part of this process yoursquoll need to review your existing

documentation ensure that the right technology is in place

to transfer UDI information to EUDAMED and the US

FDA system implement change control processes for data

updates train your employees and prepare early

CONCEPT

PROTOTYPING

PREC

LINIC

AL TR

IAL

CLINICAL TRIAL

MANUFACTURING

MARKET

ING

CO

MM

ERC

IAL

US

E

REMOVAL FROM MARKET

Fig 1 - Medical Device Life Cycle

PAGE 5

What are some of the new classification changes

Medical devices are currently classified as either Class I Class

IIa Class IIb or Class III The higher the class level the higher

the risk The MDR introduces a few classification changes

including the fact that ldquosurgical meshesrdquo ldquoactive implantable

devices or their accessoriesrdquo and ldquoall devices incorporating or

consisting of nanomaterial (if they present a high or medium

potential for internal exposure)rdquo have been added to class III

Most notably the MDR also classifies medical software as a ldquodevicerdquo (see next item)

The IVDR will introduce a new risk-assessment classification

system in which devices will be designated as belonging

to Class A B C or D (A representing the lowest risk D the

highest) Notified bodies will need to oversee class B C and

D devices while class A devices will not require input from

a notified body unless theyrsquore used for self-testing or near-

patient testing or are sold sterile

How is medical software now being classified

The MDR states that ldquoMedical device means any instrument

apparatus appliance software implant reagent material or

other article intended by the manufacturer to be used alone

or in combination for human beingsrdquo This means that apps or other programs used to prevent monitor diagnose predict or treat an ailment are all considered medical devices

Under the MDR software that provides information used for

diagnostic or therapeutic purposes will fall under class IIa

unless a certain device could cause ldquodeath or an irreversible

deterioration of a personsrsquo state of health in which case it is in

class IIIrdquo Software used to ldquomonitor physiological processesrdquo

will be designated as class IIa unless the software could

ldquoresult in immediate danger to the patientrdquo due to incorrect

monitoring In this case the device would move to class IIb

All other software will fall under class I

What are the new language requirements

As part of the regulations all devices need to be accompanied

by information in ldquoan official Union language(s) determined by

the Member State in which the device is made available to the

user or patientrdquo And the label particulars need to be ldquoindelible

easily legible and clearly comprehensible to the intended user or patientrdquo This language requirement applies to IFUs

(Instructions For Use) labeling and packaging

The MDR also states that ldquoall or certain documentsrdquo pertaining

to a device including audit assessment and inspection reports must be provided in a language chosen by the

member state in which the device is made available Bottom

line Since the EU has 24 official languages medical device

companies must be prepared to procure translation services

for their products specific to the regions in which theyrsquore sold

and marketed

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 2

When will the MDR and IVDR take full effect

2020 for the MDR 2022 for the IVDR

Why were the MDR and IVDR enacted and which key areas are changing

The MDR and IVDR replace old directives (9342EEC and

90385ECC) that were established well before the digital

age In addition to bringing the regulatory environment up to

speed on technology theyrsquore designed to pave the way for

better post-market surveillance transparency traceability

innovation and patient safety and outcomes

The new regulations expand the definition of whatrsquos considered

a medical device change some classifications introduce new

labeling requirements and generally seek better information

access for patients regulatory bodies medical practitioners

and members of the public They also create more uniform

enforcement across EU member states and in the words

of the European Council ldquohellip overcome legal gaps thereby

supporting innovation and the competitiveness of the medical

device industryrdquo

Finally with product recalls on the rise and 15 percent caused

by labelling errors (Deloitte) the new regulations seek to

prevent medical device malfunction and misuse caused by

inadequate labeling

Sweeping new regulations in a euro100 billion global market are bound to have an impact The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are certainly no exceptions

These new laws are a big win for patients But for medical device manufacturers they present significant new requirements in labeling and overall product transparency

Here are some of the top questions wersquore hearing about MDR and IVDR and our expert answers

PAGE 3

Whorsquos most affected

The new rules apply not only to medical device manufacturers

across all 28 EU member states but also to non-European companies looking to distribute or market their products inside the EU Unlike previous device directives the MDR and

IVDR are not ldquogeneral guidelinesrdquo In other words individual

EU member states wonrsquot have the flexibility to implement their

own interpretations of each regulation

What are the new labeling requirements

The two most significant changes to labeling in the new

regulations are

1 Device companies must keep device information and

Instructions For Use (IFUs) on their websites and adhere

to specific E-labeling requirements

2 IFUs must be written in terms ldquoreadily understood by

the intended end userrdquo and must contain information

on safety and clinical performance of the device where

applicable

Most of these changes are outlined in the MDR (231) which

states (emphasis added)

Each device shall be accompanied by the information needed to identify

the device and its manufacturer and by any safety and performance

information relevant to the user or any other person as appropriate

Such information may appear on the device itself on the packaging or in

the instructions for use and shall if the manufacturer has a website

be made available and kept up to date on the website taking into

account the following

231(a) the medium format content legibility and location of the

label and instructions for use shall be appropriate to the particular

device its intended purpose and the technical knowledge

experience education or training of the intended user(s) In

particular instructions for use shall be written in terms readily

understood by the intended user and where appropriate

supplemented with drawings and diagrams

The MDR goes on to state in 231(f) that ldquoInstructions for

use may be provided to the user in non-paper format (eg

electronic) to the extent and only under the conditions

set out in Regulation (EU) No 2072012rdquo This regulation

includes full requirements when labeling is provided only

electronically as well as minimum requirements for when

labeling is provided in paper format and on a website

These items present some significant challenges (eg trying

to define ldquoreadily understoodrdquo) But one thing thatrsquos clear

is the need for device-makers to develop more robust systems for label version control risk management and content management across multiple communications platforms Manufacturers should thoroughly review these

new labeling requirements determine what needs to be

changed or updated review their existing documentation

determine where everything is stored and how its integrity is

maintained ensure their labeling information is reliable and

PAGE 4

accurate and implement a content management system

that includes a revisions strategy

Whatrsquos most important about the new UDI requirements

In their effort to reduce errors improve public data access

and fight fraud the MDR and IVDR stress the importance

of monitoring medical devices throughout their lifetimes As

part of that the new regulations require that products contain

a Unique Device Identification (UDI) in addition to other

required labeling The UDI includes a Device Identifier (DI) a

Product Identifier (PI) the risk class of the device the device status (recall information summary of safety and performance

for class C or D devices) and if applicable additional product descriptions storage andor handling conditions

Placed on devices or their packaging UDIs will contain

barcodes that can be scanned to retrieve information via

EUDAMED the developing online information portal that

will include data on the devicersquos purpose description risks

warnings and precautions EUDAMED is accessible to patients

as well as the general public so all information within it

needs to be written in a way thatrsquos easily understandable for

average users not just people in the medical industry UDI

information needs to be tracked by manufacturers importers

distributors and in some cases healthcare professionals And

new UDIs are required whenever a device changes in a way

that confuses its traceability

The new UDI system impacts how you create tag and

store data You need to make sure that UDI terminology is

consistent and that correct labeling procedures are followed

so the information is usable within both EU and US systems

As part of this process yoursquoll need to review your existing

documentation ensure that the right technology is in place

to transfer UDI information to EUDAMED and the US

FDA system implement change control processes for data

updates train your employees and prepare early

CONCEPT

PROTOTYPING

PREC

LINIC

AL TR

IAL

CLINICAL TRIAL

MANUFACTURING

MARKET

ING

CO

MM

ERC

IAL

US

E

REMOVAL FROM MARKET

Fig 1 - Medical Device Life Cycle

PAGE 5

What are some of the new classification changes

Medical devices are currently classified as either Class I Class

IIa Class IIb or Class III The higher the class level the higher

the risk The MDR introduces a few classification changes

including the fact that ldquosurgical meshesrdquo ldquoactive implantable

devices or their accessoriesrdquo and ldquoall devices incorporating or

consisting of nanomaterial (if they present a high or medium

potential for internal exposure)rdquo have been added to class III

Most notably the MDR also classifies medical software as a ldquodevicerdquo (see next item)

The IVDR will introduce a new risk-assessment classification

system in which devices will be designated as belonging

to Class A B C or D (A representing the lowest risk D the

highest) Notified bodies will need to oversee class B C and

D devices while class A devices will not require input from

a notified body unless theyrsquore used for self-testing or near-

patient testing or are sold sterile

How is medical software now being classified

The MDR states that ldquoMedical device means any instrument

apparatus appliance software implant reagent material or

other article intended by the manufacturer to be used alone

or in combination for human beingsrdquo This means that apps or other programs used to prevent monitor diagnose predict or treat an ailment are all considered medical devices

Under the MDR software that provides information used for

diagnostic or therapeutic purposes will fall under class IIa

unless a certain device could cause ldquodeath or an irreversible

deterioration of a personsrsquo state of health in which case it is in

class IIIrdquo Software used to ldquomonitor physiological processesrdquo

will be designated as class IIa unless the software could

ldquoresult in immediate danger to the patientrdquo due to incorrect

monitoring In this case the device would move to class IIb

All other software will fall under class I

What are the new language requirements

As part of the regulations all devices need to be accompanied

by information in ldquoan official Union language(s) determined by

the Member State in which the device is made available to the

user or patientrdquo And the label particulars need to be ldquoindelible

easily legible and clearly comprehensible to the intended user or patientrdquo This language requirement applies to IFUs

(Instructions For Use) labeling and packaging

The MDR also states that ldquoall or certain documentsrdquo pertaining

to a device including audit assessment and inspection reports must be provided in a language chosen by the

member state in which the device is made available Bottom

line Since the EU has 24 official languages medical device

companies must be prepared to procure translation services

for their products specific to the regions in which theyrsquore sold

and marketed

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 3

Whorsquos most affected

The new rules apply not only to medical device manufacturers

across all 28 EU member states but also to non-European companies looking to distribute or market their products inside the EU Unlike previous device directives the MDR and

IVDR are not ldquogeneral guidelinesrdquo In other words individual

EU member states wonrsquot have the flexibility to implement their

own interpretations of each regulation

What are the new labeling requirements

The two most significant changes to labeling in the new

regulations are

1 Device companies must keep device information and

Instructions For Use (IFUs) on their websites and adhere

to specific E-labeling requirements

2 IFUs must be written in terms ldquoreadily understood by

the intended end userrdquo and must contain information

on safety and clinical performance of the device where

applicable

Most of these changes are outlined in the MDR (231) which

states (emphasis added)

Each device shall be accompanied by the information needed to identify

the device and its manufacturer and by any safety and performance

information relevant to the user or any other person as appropriate

Such information may appear on the device itself on the packaging or in

the instructions for use and shall if the manufacturer has a website

be made available and kept up to date on the website taking into

account the following

231(a) the medium format content legibility and location of the

label and instructions for use shall be appropriate to the particular

device its intended purpose and the technical knowledge

experience education or training of the intended user(s) In

particular instructions for use shall be written in terms readily

understood by the intended user and where appropriate

supplemented with drawings and diagrams

The MDR goes on to state in 231(f) that ldquoInstructions for

use may be provided to the user in non-paper format (eg

electronic) to the extent and only under the conditions

set out in Regulation (EU) No 2072012rdquo This regulation

includes full requirements when labeling is provided only

electronically as well as minimum requirements for when

labeling is provided in paper format and on a website

These items present some significant challenges (eg trying

to define ldquoreadily understoodrdquo) But one thing thatrsquos clear

is the need for device-makers to develop more robust systems for label version control risk management and content management across multiple communications platforms Manufacturers should thoroughly review these

new labeling requirements determine what needs to be

changed or updated review their existing documentation

determine where everything is stored and how its integrity is

maintained ensure their labeling information is reliable and

PAGE 4

accurate and implement a content management system

that includes a revisions strategy

Whatrsquos most important about the new UDI requirements

In their effort to reduce errors improve public data access

and fight fraud the MDR and IVDR stress the importance

of monitoring medical devices throughout their lifetimes As

part of that the new regulations require that products contain

a Unique Device Identification (UDI) in addition to other

required labeling The UDI includes a Device Identifier (DI) a

Product Identifier (PI) the risk class of the device the device status (recall information summary of safety and performance

for class C or D devices) and if applicable additional product descriptions storage andor handling conditions

Placed on devices or their packaging UDIs will contain

barcodes that can be scanned to retrieve information via

EUDAMED the developing online information portal that

will include data on the devicersquos purpose description risks

warnings and precautions EUDAMED is accessible to patients

as well as the general public so all information within it

needs to be written in a way thatrsquos easily understandable for

average users not just people in the medical industry UDI

information needs to be tracked by manufacturers importers

distributors and in some cases healthcare professionals And

new UDIs are required whenever a device changes in a way

that confuses its traceability

The new UDI system impacts how you create tag and

store data You need to make sure that UDI terminology is

consistent and that correct labeling procedures are followed

so the information is usable within both EU and US systems

As part of this process yoursquoll need to review your existing

documentation ensure that the right technology is in place

to transfer UDI information to EUDAMED and the US

FDA system implement change control processes for data

updates train your employees and prepare early

CONCEPT

PROTOTYPING

PREC

LINIC

AL TR

IAL

CLINICAL TRIAL

MANUFACTURING

MARKET

ING

CO

MM

ERC

IAL

US

E

REMOVAL FROM MARKET

Fig 1 - Medical Device Life Cycle

PAGE 5

What are some of the new classification changes

Medical devices are currently classified as either Class I Class

IIa Class IIb or Class III The higher the class level the higher

the risk The MDR introduces a few classification changes

including the fact that ldquosurgical meshesrdquo ldquoactive implantable

devices or their accessoriesrdquo and ldquoall devices incorporating or

consisting of nanomaterial (if they present a high or medium

potential for internal exposure)rdquo have been added to class III

Most notably the MDR also classifies medical software as a ldquodevicerdquo (see next item)

The IVDR will introduce a new risk-assessment classification

system in which devices will be designated as belonging

to Class A B C or D (A representing the lowest risk D the

highest) Notified bodies will need to oversee class B C and

D devices while class A devices will not require input from

a notified body unless theyrsquore used for self-testing or near-

patient testing or are sold sterile

How is medical software now being classified

The MDR states that ldquoMedical device means any instrument

apparatus appliance software implant reagent material or

other article intended by the manufacturer to be used alone

or in combination for human beingsrdquo This means that apps or other programs used to prevent monitor diagnose predict or treat an ailment are all considered medical devices

Under the MDR software that provides information used for

diagnostic or therapeutic purposes will fall under class IIa

unless a certain device could cause ldquodeath or an irreversible

deterioration of a personsrsquo state of health in which case it is in

class IIIrdquo Software used to ldquomonitor physiological processesrdquo

will be designated as class IIa unless the software could

ldquoresult in immediate danger to the patientrdquo due to incorrect

monitoring In this case the device would move to class IIb

All other software will fall under class I

What are the new language requirements

As part of the regulations all devices need to be accompanied

by information in ldquoan official Union language(s) determined by

the Member State in which the device is made available to the

user or patientrdquo And the label particulars need to be ldquoindelible

easily legible and clearly comprehensible to the intended user or patientrdquo This language requirement applies to IFUs

(Instructions For Use) labeling and packaging

The MDR also states that ldquoall or certain documentsrdquo pertaining

to a device including audit assessment and inspection reports must be provided in a language chosen by the

member state in which the device is made available Bottom

line Since the EU has 24 official languages medical device

companies must be prepared to procure translation services

for their products specific to the regions in which theyrsquore sold

and marketed

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 4

accurate and implement a content management system

that includes a revisions strategy

Whatrsquos most important about the new UDI requirements

In their effort to reduce errors improve public data access

and fight fraud the MDR and IVDR stress the importance

of monitoring medical devices throughout their lifetimes As

part of that the new regulations require that products contain

a Unique Device Identification (UDI) in addition to other

required labeling The UDI includes a Device Identifier (DI) a

Product Identifier (PI) the risk class of the device the device status (recall information summary of safety and performance

for class C or D devices) and if applicable additional product descriptions storage andor handling conditions

Placed on devices or their packaging UDIs will contain

barcodes that can be scanned to retrieve information via

EUDAMED the developing online information portal that

will include data on the devicersquos purpose description risks

warnings and precautions EUDAMED is accessible to patients

as well as the general public so all information within it

needs to be written in a way thatrsquos easily understandable for

average users not just people in the medical industry UDI

information needs to be tracked by manufacturers importers

distributors and in some cases healthcare professionals And

new UDIs are required whenever a device changes in a way

that confuses its traceability

The new UDI system impacts how you create tag and

store data You need to make sure that UDI terminology is

consistent and that correct labeling procedures are followed

so the information is usable within both EU and US systems

As part of this process yoursquoll need to review your existing

documentation ensure that the right technology is in place

to transfer UDI information to EUDAMED and the US

FDA system implement change control processes for data

updates train your employees and prepare early

CONCEPT

PROTOTYPING

PREC

LINIC

AL TR

IAL

CLINICAL TRIAL

MANUFACTURING

MARKET

ING

CO

MM

ERC

IAL

US

E

REMOVAL FROM MARKET

Fig 1 - Medical Device Life Cycle

PAGE 5

What are some of the new classification changes

Medical devices are currently classified as either Class I Class

IIa Class IIb or Class III The higher the class level the higher

the risk The MDR introduces a few classification changes

including the fact that ldquosurgical meshesrdquo ldquoactive implantable

devices or their accessoriesrdquo and ldquoall devices incorporating or

consisting of nanomaterial (if they present a high or medium

potential for internal exposure)rdquo have been added to class III

Most notably the MDR also classifies medical software as a ldquodevicerdquo (see next item)

The IVDR will introduce a new risk-assessment classification

system in which devices will be designated as belonging

to Class A B C or D (A representing the lowest risk D the

highest) Notified bodies will need to oversee class B C and

D devices while class A devices will not require input from

a notified body unless theyrsquore used for self-testing or near-

patient testing or are sold sterile

How is medical software now being classified

The MDR states that ldquoMedical device means any instrument

apparatus appliance software implant reagent material or

other article intended by the manufacturer to be used alone

or in combination for human beingsrdquo This means that apps or other programs used to prevent monitor diagnose predict or treat an ailment are all considered medical devices

Under the MDR software that provides information used for

diagnostic or therapeutic purposes will fall under class IIa

unless a certain device could cause ldquodeath or an irreversible

deterioration of a personsrsquo state of health in which case it is in

class IIIrdquo Software used to ldquomonitor physiological processesrdquo

will be designated as class IIa unless the software could

ldquoresult in immediate danger to the patientrdquo due to incorrect

monitoring In this case the device would move to class IIb

All other software will fall under class I

What are the new language requirements

As part of the regulations all devices need to be accompanied

by information in ldquoan official Union language(s) determined by

the Member State in which the device is made available to the

user or patientrdquo And the label particulars need to be ldquoindelible

easily legible and clearly comprehensible to the intended user or patientrdquo This language requirement applies to IFUs

(Instructions For Use) labeling and packaging

The MDR also states that ldquoall or certain documentsrdquo pertaining

to a device including audit assessment and inspection reports must be provided in a language chosen by the

member state in which the device is made available Bottom

line Since the EU has 24 official languages medical device

companies must be prepared to procure translation services

for their products specific to the regions in which theyrsquore sold

and marketed

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 5

What are some of the new classification changes

Medical devices are currently classified as either Class I Class

IIa Class IIb or Class III The higher the class level the higher

the risk The MDR introduces a few classification changes

including the fact that ldquosurgical meshesrdquo ldquoactive implantable

devices or their accessoriesrdquo and ldquoall devices incorporating or

consisting of nanomaterial (if they present a high or medium

potential for internal exposure)rdquo have been added to class III

Most notably the MDR also classifies medical software as a ldquodevicerdquo (see next item)

The IVDR will introduce a new risk-assessment classification

system in which devices will be designated as belonging

to Class A B C or D (A representing the lowest risk D the

highest) Notified bodies will need to oversee class B C and

D devices while class A devices will not require input from

a notified body unless theyrsquore used for self-testing or near-

patient testing or are sold sterile

How is medical software now being classified

The MDR states that ldquoMedical device means any instrument

apparatus appliance software implant reagent material or

other article intended by the manufacturer to be used alone

or in combination for human beingsrdquo This means that apps or other programs used to prevent monitor diagnose predict or treat an ailment are all considered medical devices

Under the MDR software that provides information used for

diagnostic or therapeutic purposes will fall under class IIa

unless a certain device could cause ldquodeath or an irreversible

deterioration of a personsrsquo state of health in which case it is in

class IIIrdquo Software used to ldquomonitor physiological processesrdquo

will be designated as class IIa unless the software could

ldquoresult in immediate danger to the patientrdquo due to incorrect

monitoring In this case the device would move to class IIb

All other software will fall under class I

What are the new language requirements

As part of the regulations all devices need to be accompanied

by information in ldquoan official Union language(s) determined by

the Member State in which the device is made available to the

user or patientrdquo And the label particulars need to be ldquoindelible

easily legible and clearly comprehensible to the intended user or patientrdquo This language requirement applies to IFUs

(Instructions For Use) labeling and packaging

The MDR also states that ldquoall or certain documentsrdquo pertaining

to a device including audit assessment and inspection reports must be provided in a language chosen by the

member state in which the device is made available Bottom

line Since the EU has 24 official languages medical device

companies must be prepared to procure translation services

for their products specific to the regions in which theyrsquore sold

and marketed

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 6

How does post-market surveillance need to be enhanced

To improve performance and prevent potential safety

issues the new regulations require much more stringent post-market surveillance plans According to the MDR

ldquomanufacturers shall plan establish document implement

maintain and update a post-market surveillance system in a

manner that is proportionate to the risk class and appropriate

for the type of devicerdquo It also requires Periodic Safety Update

Reports that should be updated annually and include a

benefit-risk determination and any necessary information

on preventative actions taken In addition the regulations

require notified bodies to perform unannounced audits at

least once every five years at manufacturer sites If necessary

a manufacturersrsquo suppliers andor subcontractors could also

be audited

Both the MDR and IVDR place stronger requirements on notified bodies with regard to conformity assessment tests for devices Under the current directives roughly 20

percent of IVDs need approval from notified bodies the new

IVDR ups that to around 80 percent

Are most products covered under the new regulations

Yes The new IVDR applies to tests for information on

predisposition to a disease tests predicting the reaction to

a certain treatment and medical software Annex XV of the

MDR lays out products that will be recognized by the rule

even though theyrsquore not technically medical devices including

contact lenses ldquoor other items intended to be introduced into

or onto the eyerdquo liposuction equipment items used for dermal

injections and products introduced into the body ldquothrough

surgically invasive means for the purpose of modifying the

anatomy or fixation of body partsrdquo

How are economic operators affected

The MDR and IVDR expand the accountability not only of

device manufacturers but also of authorized representatives importers and distributors In a kind of ldquochecks and balancesrdquo

system each economic operator must verify and document its

own compliance in the supply chain as well the compliance

of the previous link In short the days of the manufacturer

being the focus of regulatory compliance are over

Under the new regulations all non-EU medical device

manufacturers must appoint a European Authorized Representative responsible for verifying that the EU

Declaration of Conformity and technical documentation have

been created by the manufacturer and that the appropriate

conformity assessment procedure has been conducted

The Authorized Representative is legally liable with the

manufacturer if defective devices not compliant with new

regulations are put on the market

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 7

Importers must assure that products on market are CE marked

and comply with the EU declaration of conformity They must

identify the manufacturer and verify that the authorized rep

has been designated by the manufacturer and the device

must be labeled in accordance with the new regulation and

accompanied by necessary IFUs Importers must also verify

that the UDI has been assigned by the manufacturer must

label devices with their details and must have their own

vigilance report and compliance monitoring requirements

(such as a register of complaints non-conforming devices

recalls and withdrawals)

Distributors must verify that the device has been CE marked

that the EU declaration of conformity has been drawn up and

that the device is accompanied with necessary information

in accordance with MDR Article 10(11) They must verify that

the importer has complied with the requirements set out in

MDR Article 12(3) And where applicable they must ensure

that the UDI has been assigned by the manufacturer

When should I start taking action to comply

As soon as possible The MDR and IVDR represent a sizable

change in scope classification and regulatory obligations

Yoursquoll likely need to recalibrate your processes which

requires communication with notified bodies and time for

implementation Also keep in mind that companies wonrsquot be

ldquograndfathered inrdquo to the MDR and IVDR You must meet the

new requirements by the enforcement dates

Fig 2 - A Projected MDR Timeline

bull MDR enforced in full

bull Medical Devices that do not comply with the MDR may no longer be placed on the market

bull EUDAMED goes live (implemental plan TBD final in May 2018)

bull UDI carriers must be on implantable devices and class III devices

bull Exemptions filed in accordance with 90385EEC + 9342EEC prior to May 25 2017 expire

bull UDI carriers must be on class IIa and IIb devices

bull Exemptions filed after May 25 2017 expire

bull UDI carriers must be on class I devices and devices lawfully placed on the market in accordance with the MDD need to be off the marketoff service

2020

2021

2022

2023

2024

2025

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom

PAGE 8

References

bull Regulation Of The European Parliament And Of the Council On Medical

Devices (MDR) httpdataconsiliumeuropaeudocdocumentST-10728-

2016-INITenpdf

bull Council of the European Union (2017) Draft Statement of The Councilrsquos

Reasons Retrieved from httpdataconsiliumeuropaeudocdocument

ST-10728-2016-ADD-1enpdf

bull Lloydrsquos Register LRQA (2017) In Vitro Diagnostic Device Regulation Are

You Prepared For The Changes Retrieved from httpwwwlrqausa

comCertificationivdr-invitro-diagnostic-device-regulation

bull Safar L (2016) Life Sciences Regulatory Updates In The EU Multilingual

September 2016 52-56

bull Cromsource (2016) Changes To EU Medical Device Legislation What

You Need To Know Retrieved from httpswwwcromsourcecom

wp-contentuploads201212Changes-to-EU-Medical-Device-legislation-

What-you-need-to-know-White-paper-2016pdf

bull Regulation Of The European Parliament And of the Council on In Vitro

Diagnostic Medical Devices (IVDR) httpdataconsiliumeuropaeudoc

documentST-10729-2016-INITenpdf

bull MedTech Europe (2015) The European Medical Technology Industry ndash In

Figures Retrieved from httpwwwmedtecheuropeorgsitesdefault

lesresource_items lesMEDTECH_FactFigures_ONLINE3pdf

bull Enriquez J (2015) Report By 2020 Global Medtech Market Worth

$4775 Billion Medtronic Top Device Maker Retrieved from https

wwwmeddeviceonlinecomdocreport-by-global-medtech-market-

worth-billion-medtronic-top-device-maker-0001

Barcelona

Galway

Heidelberg

United Language Group ndash US Headquarters

Locations Worldwide

Contact Us

Hong Kong

London

Los Angeles

Mumbai

Munich

New York

1600 Utica Avenue South

Minneapolis MN 55416

unitedlanguagegroupcom