regulatory framework for in vitro diagnostic medical devices
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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
Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are not owned by the
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