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Posted 24 May 2022 | By Gareth Macdonald 

MDCG sets out transition periods for legacy diagnostics post-IVDR

2868 The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market after the In Vitro Diagnostic Regulation (IVDR) comes into application.
 
The new timelines are set out in a guideline covering legacy devices that are placed on the market before May 26, which is the date the transition period from the current IVD Directive (IVDD 98/79/EC) ends.
 
A legacy device is either: a device with an EC certificate issued by a notified body under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) prior to 26 May 2022; or one for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body.
 
The length of time such devices will be allowed to remain on the market depends on when they were launched, according to the MDCG guideline.
 
“For devices covered by a valid EC certificate issued in accordance with the IVDD prior to 26 May 2022 (i.e. devices listed in Annex II IVDD and devices for self-testing), the transition period ends on 26 May 2025 (see 2nd subparagraph of Article 110(3) IVDR).
 
“If placed on the market before 26 May 2025, those devices may continue to be made available until 26 May 2026 (“sell-off date,” see 2nd subparagraph, point (a) of Article 110(4) IVDR).”
 
Risk factor
 
Under IVDR, devices are grouped by the relative risk they are deemed to pose to patient and public health, with risk based on the extent to which the device comes into contact with biological materials or other hazardous agents.
 
These risk groups also play a part in determining how long legacy devices will be allowed to remain on the market.
 
For example, class D devices – which are deemed to pose the highest risk to patients and public health – with a declaration of conformity drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body, the transition period ends on 26 May 2025.
 
If placed on the market before 26 May 2025, those devices may continue to be made available until 26 May 2026, defined as the “sell-off date,” under the 2nd subparagraph, point (a) of Article 110(4) IVDR).
 
Similarly, for class C devices – which are deemed to pose a high risk to patients and a moderate risk to public health - the transition period ends on 26 May 2026. Class C devices on the market before that date may continue to be made available until 26 May 2027.
 
 
Finally, for class A and B legacy devices that meet the criteria, the transition period ends on 26 May 2027, with the sell-off date for products launched before the end of the transition period being 2028.
 
Post-market surveillance
 
The MDCG guideline also underlines the requirement that manufacturers of legacy devices set up a post-market surveillance (PMS) system to monitor how such products perform.
 
The authors wrote “As part of the manufacturer’s post-market surveillance system, the post-market performance follow-up (PMPF) requirements (Annex XIII, Part B, IVDR) should apply to legacy devices.”
 
PMPF further develops the requirement in Annex III, section 5, of the IVDD6. That means that, under the IVDR, manufacturers need to “proactively collect and evaluate performance and relevant scientific data from the use of a device”.
 
“However,” the authors continue “this does not mean that the manufacturer would have to draw up, retrospectively, a performance evaluation report in line with the IVDR as performance evaluation and its documentation according to the IVDR is a pre-market requirement not applicable to legacy devices.”
 
Industry response
 
Publication of the MDCG guideline comes six months after the Commission delayed the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) citing the lack of notified body capacity as a factor.
 
At the time, industry group MedTech Europe welcomed the decision, writing that, “It is important that the European Commission seeks to safeguard the availability of in vitro diagnostic tests to patients and healthcare systems, particularly in a challenging pandemic situation, while transitioning into the Regulation.”

 

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