Presentation of the 18th ECDC National Focal Points for Microbiology (NMFP) meeting held on 3-4 May 2018 in Stockholm

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
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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
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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.
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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
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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
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12. 12
The European governance map

13. (work in progress)

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)
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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)
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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)
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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))
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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
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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)

23. THANK YOU
FOR YOUR ATTENTION
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