9/10/07 1

Carl Youngmann, PhDRegulatory Affairs Certified

Port Townsend, Washington

(360) 379 3660

CYoungmann@gmail.com

Medical Devices for the EU

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27 member states of theEuropean Union• Austria

• Belgium

• Bulgaria

• Cyprus

• Czech Republic

• Denmark

• Estonia

• Finland

• France

• Germany

• Greece

• Hungary

• Ireland

• Italy

• Latvia

• Lithuania

• Luxembourg

• Malta

• Netherlands

• PolandPortugal

• Romania• Slovakia• Slovenia• Spain• Sweden• United

Kingdom

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The European Free TradeAssociation (EFTA)

• 3 of the 4 states ofthe EFTA are part ofthe EEA internalmarket:– Iceland– Norway– Liechtenstein

• The fourth state,Switzerland, hasbilateral agreementswith the EEA.

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US versus EU Medical DeviceRegulation

• Directives to Member States– Implemented by Member State parliaments

in national legislation– Overseen by national Competent Authorities– Compliance checked by Notified Bodies– Enforcement under national jurisdiction

• Based on compliance not notice or approval• No EU centralized authority• Different approach to determining standard

of care: national health systems,

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The U.S. compared to the E.U.-1

Design Controls

Personnel /Training

Audits

Managementresponsibility

Quality PlanningQuality System& Policy

Quality Plan

Few definitionsMore definitions

ISO 1348521 CFR 820Quality System

EU specificSharedUS specific

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The U.S. compared to the E.U.-2

Corrective &Preventative Action

NonconformingProduct

Measurement &Test Equipment

Inspection

Process Control

ProductIdentification

PurchasingQuality System,continued

EU specificSharedUS specific

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The U.S. compared to the E.U.-3

Complaints

Quality Records

Installation

Handling,Storage &Delivery

TranslationPackagingLabelingDevice MasterRecordDevice HistoryRecord

Quality System,continued

EU specificSharedUS specific

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The U.S. compared to the E.U.-4

MDD EssentialRequirements

BiocompatibilityFDA GuidanceProductRequirements

Electrical Safety

ElectromagneticCompatibility

ISO 14971Risk Management

StatisticalTechniques

ServicingQuality System,continued

EU specificSharedUS specific

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The U.S. compared to the E.U.-5

SterilizationValidation

Post MarketSurveillance

Recalls &Removals

MDRPost Market

Technical FileCE-Marking

510(K), IDE &PMA

RegulatoryCompliance

AuthorizedEuropeanRepresentative

U. S. Agent forDevices

Representation

SterilePackaging

shelf-lifesterile barriershipping

ProductRequirements

continued

EU specificSharedUS specific

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The U.S. compared to the E.U.-6

ISO 14155-1, -2IDEClinical

Auditsinitialcontinuing

Inspectionsbiennial GMPpre-PMA

Assessments

EU specificSharedUS specific

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The CE Mark

• Possibly CommuniteeEuropéen, French forEuropean Community.

• Could be ConformitéEuropéen.

• Invented by somebureaucrat in Brussels.

• Officially, just a logoand has no linguisticmeaning.

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Medical Device Directives

• Medical Devices — Council Directive93/42/EEC of 14 June 1993 (OJ No L 169/1 of1993-07-12)

• Active Implantable Medical Devices —Council Directive 90/385/EEC of 20 June1990 (OJ No L 189/17 of 1990-07-20)

• In-vitro diagnostic medical devices —Directive 98/79/EC of 27 October 1998(1998-12-07 OJ No L 331/1)

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Recent Changes to the MDD

• Clarification of design documentation anddesign review requirements

• Clarification of the clinical evaluationrequirements

• Substances of animal origin or containinghuman blood

• Software validation• Alignment of the original MDD 93/42/EEC

with other directives

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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 1

• 23 Articles– Definitions, scope– Placing on the market and

putting into service– Essential requirements– Free movement, devices

intended for special purposes– Reference to standards– Committee on Standards and

Technical Regulations– Safeguard clause– Information on incidents

occurring following placing ofdevices on the market

– Classification– Conformity assessment

procedures– Registration of persons

responsible for placing deviceson the market

– Clinical investigation– Notified bodies– CE marking and Wrongly

affixed CE marking– Confidentiality– Implementation, transitional

provisions

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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 2

• 12 AnnexesI Essential RequirementsII EC Declaration of Conformity (Full Quality

Assurance – ISO 13485 + MDD )III EC Type - ExaminationIV EC Verification i.e. batch testingV EC Declaration of Conformity (Production

Quality Assurance – ISO 13485 MDD)VI EC Declaration of Conformity (Product

Quality Assurance – ISO 13485 + MDD)

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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 3

• 12 AnnexesVII EC Declaration of Conformity, self-

certification for Class I productsVIII Statement concerning devices for special

purposesIX Classification criteria i.e. rules for the

classification of productsX Clinical evaluationXI Criteria for the designation of Notified

BodiesXII CE Marking of conformity

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CE-Marking Medical Devices

• Classify the device• Assess device conformity

– Essential Requirements– Risk Management– Certification Procedures

• Performance• Quality

– Labeling– Technical construction file or design dossier

• Authorize a European representative• CE mark the product

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MDD Device Classification

• Duration of use: transient, short-termor long-term

• Invasiveness: non-invasive, bodyorifice, surgically invasive, implantable

• Activity: therapeutical or diagnostic• Central circulatory contact• Central nervous system contact

MDD Annex IX

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4 ( Really 6 ) Device Classes — 1

• Class I – low risk–non-sterile dressings–bandages–hospital gowns– light sources

• Class I (Sterile)–disposable surgical instruments–urine drainage bags

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4 ( Really 6 ) Device Classes — 2

• Class I (Measuring)–scales–digital thermometers

• Class IIa – medium risk– IV catheters– tubings for anesthesia / ventilation–ultrasound devices

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4 ( Really 6 ) Device Classes — 3

• Class IIb – elevated risk– intra-ocular lenses

–breast implants

–endoprostheses

–ventilators

• Class III – high risk–heart valves

– reabsorbable implants

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Class I Conformity Assessment

• Manufacturer self-declares conformity

for performance

and

for quality system

• Aspects of sterile products and measuringdevices relating to sterility and/or metrologyare certified by a Notified Body.

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Class IIa Conformity Assessment• Manufacturer self-declares conformity

for performanceandfor design control

• Notified Body must– certify full quality assurance system– certify production quality assurance system– certify final inspection and testing; or– exam and test sample products.

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Class IIb Conformity Assessment

• Notified Body will either

certify full quality assurance system

or

test and certify product performanceandcertify production quality assurance system

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Class III Conformity Assessment• Notified Body will

certify full quality assurance system

and

certify the technical dossier

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Technical Construction File (Class I & II)or Design Dossier (Class III)

• Essential Requirements Analysis– Product design specifications– Hazard and risk analysis– Verification and validation reports

• Engineering test reports• Laboratory reports• Clinical validation

– Product labeling• A combination of elements from the Design

History File and the Device Master Record

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Declaration of Conformity• Document created by the person placing the

device on the market that clearly identifies:– The manufacturer or their AER– Manufacture’s or AER’s European Address– The device (models, serial numbers, lots,

etc.)– The applicable directives– The major standards complied with– Signed by a responsible authority

• Included in the device labeling, usually in theinstructions for use and shipping documents

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Lumps in the Level Playing Field

• Each Member State was permitted toimpose requirements particular to theirnational cultures, i.e., use of languagesindigenous to their countries

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EU National Language Requirements -1

EstonianEstonia

DanishDenmark

CzechCzech Republic

Non-professional use devices in Greek. ProfessionalUse devices in Greek or English

Cyprus

CroatianCroatia (PendingEU state)

English, Bulgarian for self-test devices only.Bulgaria

Dutch + German + French (All three must be used forpatient instructions)

Belgium

GermanAustria

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EU National Language Requirements - 2

ItalianItaly

EnglishIreland

IcelandicIceland (EFTA)

HungarianHungary

GreekGreece

GermanGermany

FrenchFrance

Finnish + SwedishFinland

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EU National Language Requirements - 3

NorwegianNorway (EFTA)

DutchNetherlands

Maltese or EnglishMalta

Macedonia(Pending EUState)

FrenchLuxembourg

LithuanianLithuania

GermanLiechtenstein(EFTA)

Latvian for professional use; English or German isaccepted

Latvia

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EU National Language Requirements - 4

SwedishSweden

SpanishSpain

SlovenianSlovenia

SlovakSlovakia

SerbianSerbia

RomanianRomania

PortuguesePortugal

PolishPoland

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EU National Language Requirements - 5

EnglishUnited Kingdom

TurkishTurkey (PendingEU State)

French, German, ItalianSwitzerland(EFTA)

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How to label a device formarketing in Europe - 1

• Highly simplified instructions– Fourth grade vocabulary– Simple declarative sentences– No or minimal medical terminology– Maximum use of graphics

• Graphics!

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How to label a device formarketing in Europe - 2• Limit marketing to a few of the largest countries, e.g., UK (61M),

France (64M), Germany (84M), Italy (54M) & Spain (45M) toreach 62% of the 494M EU residents

– Label only for those markets

• Sell products F.O.B. in market countries, others in the EU canpurchase across borders

• Require training for professionals and service personnel wheremore complete materials can be provided in English

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Post-Market Surveillance

• Manufacturer must establish systems to–Record and analyze customer

responses–Process customer complaints–Collect, report and analyze any

adverse events–Actively monitor use and abuse of the

product

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Authorized European Representative(AER)• A point of contact within the EU where the Competent

Authorities can serve notices

• Generally not a sales office or a business facility

• Required to be shown on all labeling

• Only one required for the entire EU– Establishes the country of legal jurisdiction for criminal

and civil actions, including insurance

• Should be knowledgeable in the mechanics of the MDD

• May be required to respond within 2-3 days with technicalfile

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Questions?

• Ask the EU Commission:ec.europa.eu/enterprise/medical_devices/index_en.htm