Regulatory framework for in vitro diagnostic medical devices

Olga Tkachenko, DG for Health and Food Safety, European Commission

22 April 2021

In vitro diagnostic medical devices

Biomarkers

Genetic testing

Cancer diagnostics

Blood grouping

Infectious agents

…

…

Revamp of EU regulatory framework for IVDs

Directive 98/79/EC on in vitro diagnostic medical devices

Regulation on IVD 2017/746

adopted in April 2017

date of application 26 May 2022

What the new Regulation brings

Areas of the regulatory framework

Pre-market Post-market

Vigilance

Market surveillance

(competent

authorities)

Qualification/

classification

Performance

evaluation/

performance study

Conformity

assessment

Post-market

surveillance

(manufacturer)

What does the new Regulation bring?

Higher standards of evidence

Transparency and traceability

Greater harmonisation

Higher standards of evidence

• Stricter requirements for designation of notified bodies*

• More adequate, risk-based device classification system

• Stronger and clearer requirements for performance evaluation and post-

market surveillance of devices

• Greater involvement of notified bodies in conformity assessment

• New scientific structures for high-risk devices: expert panels and EU

reference laboratories

What does the new Regulation bring?

*notified bodies – third party bodies which assess manufacturers, designated and

overseen by the competent authority (can be private)

Transparency and traceability

• Centralised information in the new Eudamed database

• Comprehensive database of devices and economic operators

• Substantial parts available to the public

• Unique Device Identifier system

• For devices of higher risk classes, summary of safety and performance for

the user and, if relevant, to the patient

What does the new Regulation bring?

Greater harmonisation

• Regulation (directly applicable) vs Directive

(needs to be transposed)

• Clearer obligations for various economic operators

• EU-level conditions for devices manufactured and used in the same health

institution

• Greater cooperation between Member States (Medical Device

Coordination Group)

• Greater cooperation between notified bodies (coordination group)

What does the new Regulation bring?

In-house devices exemption

Manufactured and used in the same health institutionfor a medical purpose

Excluded from most of the IVDR

Some of the conditions (not exhaustive, see Art 5(5)):

No transfer to another legal entity

Manufacturing under an appropriate quality management system

Health institution justifies in its documentation that the patient's needs cannot be metby a marketed device

It provides a publicly available declaration

For class D (highest risk) devices, the health institution draws up documentationabout manufacturing

Member States have the right to inspect the health institution

Progress with implementation

How we work on implementation of medical device legislation

• Regular review by the Medical Device Coordination Group

• An implementation plan with concrete actions and timelines

• Market monitoring exercise – quantitative and qualitative

Progress with the implementation

• All obligatory legal acts adopted (notified bodies, expert panels)

• 4 notified bodies designated

• IVD expert panel appointed

• Implementing act on standardisation request to CEN/CENELEC adopted

• Guidance on classification published

• Guidance on transitional provisions for class D devices published

Progress with the implementation - completed

• 10 NB designations

• Construction of Eudamed, UDI, nomenclature

• Implementing act on common specifications for 14 types of high-risk devices

• 7 guidance documents

Progress with the implementation – ongoing 1

• Performance evaluation

• Devices in clinical trials of medicines

• Notified body designation codes

• Batch testing

• Consultation of expert panel

• Summary of safety and performance

• In-house devices (manufactured and used

in the same health institution)

• EU reference laboratories for high-risk devices – not obligatory but of high

added value

• 2 implementing acts on tasks, criteria and fees

• Survey to estimate needed capacity

• Discussion with Member States on practical aspects

• Preparation of a first call for application covering most of class D devices

Progress with the implementation – ongoing 2

Challenges

Notified body capacity

Low risk device (A):

Self-certification by manufacturer

Medium risk device (B,C):

Proportionate involvement of notified body

High risk device (D):

Full assessment by notified

body

Need notified bodies

Under Directive:

~10% of IVDs

need a notified body

Under Regulation:

~95% of IVDs

need a notified body

Data from MedTech Europe

Overview of notified body designation processes

5242 40

3528

21 21 21 20 20

14

11

3

76

6

5 4 4 4 4

0

10

20

30

40

50

60

70 as of 15 April 2021

IVDR - Regulation (EU) 2017/746MDR – Regulation (EU) 2017/745

(18 notified bodies designated under the IVD Directive)

• Conformity assessment process with a notified body estimated to last

minimum 9-12 months

• After certificate is issued, industry reports need for further several months

(ideally 6) to bring device to market

• Now 13 months to application date

Readiness of manufacturers

• Number of certificates issued by notified bodies under the Directive (~10% of

IVD market) - ~1500

• Expected number of certificates under the Regulation (~95% of IVD market)

is several thousand

• Current number of applications to notified bodies under the IVDR (February

2021) – 249

• Current number of NB certificates issued under the IVDR (February 2021) – 7

Readiness of manufacturers

Manufacturers are applying to notified bodies

in extremely low numbers

• The new Regulation reinforces the standards of evidence, brings greater

transparency, traceability and alignment of rules and actors across the EU

• A number of implementation milestones achieved or in an advanced stage

• All obligatory implementing legislation in place

• Significant challenges remain

• Overall capacity of current and foreseen notified bodies is low

• Manufacturers have been applying to notified bodies in very low numbers

Conclusions

• The new Regulation reinforces the standards of evidence, brings greater

transparency, traceability and alignment of rules and actors across the EU

• A number of implementation milestones achieved or in an advanced stage

• All obligatory implementing legislation in place

• Significant challenges remain

• Overall capacity of current and foreseen notified bodies is low

• Manufacturers have been applying to notified bodies in very low numbers

Conclusions

Engagement and cooperation of all actors is essential

to bring the benefits of the IVDR into practice

Thank you

© European Union 2021

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