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The In vitro diagnostic medical devices regulation (EU) 2017/746: what will change for public health laboratory services?
1. European Commission
DG Internal Market, Industry,
Entrepreneurship and SMEs
The In Vitro Diagnostic Medical Devices Regulation (EU)
2017/746: what will change for public health laboratory
services?
2. Directive 90/385/EEC on active implantable medical devices
Directive 93/42/EEC on medical devices
Regulation on medical devices 2017/745
Directive 98/79/EC on in vitro diagnostic medical devices
Regulation on IVD 2017/746
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-
framework_en 2
Revision of the EU Medical Devices
Legislation
3. Regulation on medical devices 2017/745
Regulation on IVD 2017/746
Independent from Health Technology Assessment (HTA),
including 2017 Commission initiative on strengthening HTA
3
Revision of the EU Medical Devices
Legislation
4. Scope
Abridged definition (see Art. 2 IVDR):
•reagent, … kit, ... instrument, ... software, ... system etc
•intended by the manufacturer for in vitro examination of
specimens derived from the human body
•concerning a physiological or pathological process or
state, predisposition to a disease, to determine safety and
compatibility with potential recipients, ...
5. Clarification of the scope
Software
Genetic tests, companion diagnostics
Internet sales
IVDs used for diagnostic or therapeutic services offered
at a distance
International reference materials are excluded
Medical devices that come into contact with human body
are governed by a separate but similar Regulation
2017/745.
6. Principles of placing on the market
Manufacturers are primarily responsible for compliance
of devices with Regulation
For very low risk devices, the manufacturer may declare
conformity of their product
For higher risk devices, conformity is certified by a
notified body – an independent conformity assessment
body designated by a government authority
7. State of play regarding the new
Regulation and next steps
• Publication of the IVD Regulation in the OJ the 5th
of May 2017
• Date of application: 26 May 2022
• Transitional provisions apply
• Medical Device Coordination Group established
• Adoption of secondary legislation (Implementing
acts) ongoing, e.g. Common Specifications
• Guidance to be drafted to facilitate implementation
of the Regulation (e.g. classification, performance
evaluation studies, companion diagnostics…) 7
8. Key derogations (1)
6 months after
entry into force
• Requirements
on Notified
Bodies
• Establishment
of the MDCG
12 months
after entry into
force
• Cooperation
among
Competent
Authorities
18 months
before the date
of application
• Designation of
reference
laboratories for
IVDs
8
9. Key derogations (2)
0-7 years after
date of
application
• Coordinated
procedure for
assessment of
performance studies
2 years after
date of
application
• Certificates issued
under old
Directives:
maximum period of
validity of 2 years
after entry into
application
3 years after
date of
application
• Devices placed on
the market under
old Directives prior
to the date of
application may
continue to be made
available on the
market or put into
service for 3 years
after that date.
9
10. • Reinforced designation and oversight processes of notified bodies.
• Stricter pre-market control of high-risk devices (class D) with the involvement of an
EU reference laboratory and/or a pool of experts at EU level.
• Establishment of a comprehensive EU database on medical devices (EUDAMED) and
of a device traceability system.
• Reinforcement of the rules on performance evaluation and performance studies,
including introduction of a coordinated assessment of a performance study
conducted in more than one Member State.
• Improved coordination between Member States in the fields of vigilance and market
surveillance.
• Stronger role for the Commission in the context of decisions on the regulatory
status of products.
• Specific regime for devices manufactured and used in the same health institution
('in-house devices').
• Clarification of the role and responsibilities of economic operators. Certain new
obligations for manufacturers, authorised representatives, distributors and
importers.
Main new features of the Regulations
10
11. • Prescribed by the legal text
• Will include:
• Registration of devices, UDI and registration of economic operators
• Notified Bodies and certificates
• Performance studies
• Vigilance and post-market surveilllance
• Market surveillance
• Public and restricted parts
• Fully accessible to CAs and Commission
• Partial access for Notified Bodies, manufacturers, public
The EUDAMED database
11
14. • To be set up by 25 November 2020
• Criteria for eligibility laid down
• Horizontal roles: provision of scientific advice, contribution to
development of analysis methods, etc
• Regulatory roles: for class D devices, verification of
performance, compliance with Common Specifications and batch
testing.
• Designated by the Commission
• Shall form a network to coordinate and harmonise their working
methods
• Subject to on-site visits and audits by the Commission
EU Reference Laboratories
(Art.100 IVDR)
14
15. • May charge fees for services to Notified Bodies and Competent
Authorities
• May also be granted Union financial contribution
EU Reference Laboratories
(Art.100 IVDR)
15
16. • General requirements on expertise and no conflict of interest laid
down
• For IVD provide views on the performance evaluation of devices
for which no common specifications are available and where it is
the first certification of that type of device
• Designated by the Commission
Expert panels (Art.106 MDR)
16
17. 'In house' exemption
Exemption of devices manufactured and used in the same
health institution from the Regulation but subject to the
general safety and performance requirements in Annex I
‘Health institution’ – an organisation the primary purpose of
which is the care or treatment of patients or the promotion of
public health (Art. 2 (29))
17
18. 'In house' exemption
Conditions:
No transfer to another legal entity
Laboratory accredited and compliant with EN ISO 15189
The health institution draws up and maintains documentation for the
manufacture of the device
It justifies in its documentation that the patient's needs cannot be met by a
marketed device
It provides a publicly available declaration
Guidance currently being developed:
https://www.gov.uk/government/consultations/health-institution-
exemption-for-ivdrmdr
18
19. • Current system→ Two positive lists: A and B (Annex II to
Directive 98/79/EC)
• New system → risk-rule based classification
• 4 classes based on Global Harmonization Task Force
A: low individual risk and low public health risk
B: moderate individual risk and/or low public health risk
C: high individual risk and/or moderate public health risk
D: high individual risk and high public health risk
• 7 classification rules (Annex VIII)
Risk classification
20. • Manufacturer proposes the classification based on intended
purpose
• For classes B, C, D (and A sterile), this is verified by notified
body
• In cases of dispute, national Competent Authority arbitrates
• Commission, in consultation with MDCG, may take
decisions either on request of a CA or on its own initiative
• Guidance is in preparation by a task force of IVD TG, ready by
end of 2018
Who performs the risk classification?
21. Conformity assessment depends on class
•Class A: self-certification (unless sterile)
•Class B, C and D : proportional assessment of quality management
system, technical documentation etc. by a notified body
•Class D:
if designated, EU Reference Laboratory to verify claimed
performance and compliance with the applicable Common
Specifications (laboratory tests)
If no Common Specifications and first certification for that
type of device: application of the 'scrutiny mechanism'
(consultation of expert panel)
•Companion diagnostics: consultation procedure with a pharmaceutical
authority
22. • A Competent Authority may grant derogation from
conformity assessment for a device on their territory
• Commission may extend this to the whole Union and set the
conditions
In case of a public health emergency
(Art. 54)