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T h e r e s e . A l b i n s s o n @ m e d q t e c h . s e

QA Regulatory forum: Classification and Risk assessment according to MDRDate : 05.04.2018

MedQtech ABMedQtech AB is a consultant business within the medical device industry. We support and help ourcustomers in the fields of quality and regulatory compliance.

My background:

▪ Over 15 years within Medical Device Industry

▪ Support in ISO 13485 Certification,

▪ Support in Medical Device CE-marketing process

▪ Regulatory strategy support

▪ Compliance MDD/MDR IVDD/IVDR

▪ Facilitation of Risk Management, ISO 14971,

▪ Internal audits, supplier audits

IVDR – In vitro Diagnostics

Classification and risk based rules

Risk based rulesRISK

Annex II list A

Annex II list B

Other

Class B

Class C

Class D

Class A

RISK

IVD IVDR

Ref. MDR & IVDR EU Conference 2017

Article 47 – Classification of devices

Class A,

Low individual risk and low risk to public health

Class B,

Moderate individual risk and/or low risk to public health

Class C,

High individual risk and/or medium risk for public health

Class D,

High individual risk and high risk for public health

Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks.

Class C & D Require Quality Management System surveillance of Notified bodyRef. IVDR, Article 48, Annex IX

Class B, C & D EU technical documentation assessment certificate by Notified BodyRef. IVDR , Article 48 , Annex IXClass A

Self-certify ( if sterile IVDs need assessment by NB)Ref. IVDR, Article 48

Rule 1 Rule 2 Rule 3 Rule 4 Rule 5 Rule 6 Rule 7

Blood screening

High risk diseases

Class D

Blood grouping

High risk dissades

Class C Class D

High risk blood groups

Infection diseases

Cancer testingCompanion diagnostics

Geneteic testing

….

Class C Class C Class A Class B Class B

Self testing

High risk near patient test

Blood gasesBlood glucose

…

Class B

Self test for non-critical conditions

General laboratory use

Non-critical accessories

Buffer solutions

Instruments

None of the other rulse

Unassayed conrols

IVDR - ANNEX VIII – Classification Rules

Class D

Class C

Class A

Class B

May self-certify, but Class A sterile IVDs require an assessment by the NB of the sterile aspects according to Annex IX (or Annex XI).

Require quality systems (Annex IX except Chapter II)NBs sampling at least one technical file per generic device group as part of on-site audits unless these devices are self-testing or near-patient testing, in which case the technical documentation of all devices need to be assessed.

Require either a full quality management system combined with a review of the technical documentation of at least one device per generic device group (Annex IX except Chapter II), or an EC type-examination (Annex X) together with production quality assurance or EC verification (Annex XI).

Requires the same procedure as Class C, plus batch verification and reference laboratory involvement (Annex IX). (Alternatively Annex X and Annex XI certification is possible.)

Ref. IVDR, article 48,

MDR – Medical Device Regulations

Classification and risk based rules

Class I,

Self-certify, register to competent authority

Class Is, Im, Ir

Partly Notified body

Registered to competent authority

Class IIaClass IIb

Class III

Devices shall be divided into Classes I (Is, Im, Ir), IIa, IIb and III taking into account the intended purpose of the devices and their inherent risks.

Classification shall be carried out in accordance with Annex VIII.

Require Notified Body Review of technical documentation Audit of Quality Management System

Article 51 - Classification of Device

ANNEX VIII – Classification Rules

MDR -> 22 rules

Rules 1-4: Non-invasive devices

Rules 5-8: Invasie devices

Rules 9-13 : Active Devices

Ruleas 14-22 : Special rules

MDD -> 18 rules

Rules 1-4: Non-invasive devices

Rules 5-8: Invasie devices

Rules 9-12 : Active Devices

Ruleas 12-18 : Special rules

5 new rules, some changes in existing rules and new class Ir, one rules in MDD has been dissmissed (rule 18)

Rule 3 Rule 4

Rule 6

Rule 8

Rule 11

Rule 18

Rule 19

All non-invasive devices

consisting of a substance or a

mixture of substances

intended to be used in vitro in direct contact with human

cells, tissues or organs taken

from the human body or used in

vitro with human embryos

before their implantation or administration into the body

are classified as class III.

This rule applies also to the

invasive devices that come into contact with

injured mucous membrane.

Reusable surgical instruments in

Class I, But a new

classification, Class Ir, applies

Added exemption of implantable

devices to be classified as

class III

New rule for classification of

software.

Class I, IIa, IIb, III

State that non-viable tissue of

human or animal cells will be

considered Class III.

Newclassifies nano-

materials depending on

their potential for internal exposure. Class IIa, class IIb,

Class III

MDR - ANNEX VIII – Classification RulesRule 20

NewPlaces devices intended for inhalation of

medicinal substances in

risk Classes IIa or IIb.

Rule 21

Newplaces devices composed of

substances absorbed or dispersed in

different classes based on their level

of internal exposure.

Rule 22

Newplaces active

therapeutic devices with an integrated

diagnostic function, which provides data

on patient management

Class III

What to do ???

• Intended use

• Re-classify your product under the new IVDR/MDR • Create a “Classification document”. • Explain the rules/rationales and the class for your device

• Set your Regulatory Strategy based on the class of the product.