Table of Content
On 06.01.2023, the European Commission published a legislative proposal for a further extension of the transition periods of the MDR. This proposal has now been approved by the European Parliament. This gives rise to the following questions:
- What is the current state of play?
- What conditions are associated with the extension of the transition periods?
- What new transition periods for medical devices now apply?
- The sell-off period is to be eliminated. What does this mean?
- What changes to the MDR’s usability requirements?
We want to answer these questions for you in this article and thus provide clarity.
The current status
Since 16.02.2023 it is certain: The European Parliament has approved the proposal of the European Commission to amend the Medical Device Regulation. Following the EU Parliament, the Council of the EU states has now also given its approval. Now all that remains is for the Parliament and the states to formally adopt it. This is expected to happen in mid-March 2023. The changes will then take effect when they are published in the Official Journal of the EU.
The most important innovation here: the transition periods for existing products have been extended.
The reason for this: Supply bottlenecks for medical devices that would not make the “move” to the MDR requirements in time are to be avoided.
In a press release, the European Commission cites the following as the reason „[…] to allow manufacturers and notified bodies additional time to transition from the previously applicable rules to the requirements of the Regulation, subject to specific conditions.“ (source: European Commission)
But why is this necessary? The following reasons are given:
- “The transition to the new rules has been slower than anticipated”
- „The COVID-19 pandemic“
- “a risk of significant disruption in the supply of various medical devices on the market “
- „the overall capacity of notified bodies remains limited for ensuring a successful transition to the new regulatory framework“
- „a risk of significant disruption in the supply of various medical devices on the market“
(source: European Commission)
This press release from the European Commission further states: „Without any legislative action, there is a risk of significant disruption in the supply of various medical devices on the market, affecting healthcare systems and their ability to provide care to European patients. “
(source: European Commission)
What conditions are associated with the extension of the MDR transition periods?
The European Commission states: „the extended transition period applies only to ‘legacy devices’, i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.“ (source: European Commission)
In addition, the following conditions are imposed. The periods will be extended only for products …
- … that are already safe.
- … for which the manufacturer has already taken measures to transition to the MDR.
Another special case exists for implantable custom devices, which are assigned to Class III: Only if a conformity assessment was applied for before May 26, 2024, the transition period is extended until May 26, 2026.
What are the new MDR transition periods for medical devices now?
An important note at the beginning: The MDR continues to apply to all new medical devices. Nothing has been moved backwards here!
The transition periods only apply to all medical devices whose conformity assessment was completed BEFORE May 26, 2021. They are staggered according to risk class and look as follows:
Class I: 26.05.2021 (nothing changes here!)
Class Ir: 31.12.2028
Class Is: 31.12.2028
Class Im: 31.12.2028
Class IIa: 31.12.2028
Class IIb: 31.12.2028
Class IIb (implantable devices): 31.12.2027
Class III: 31.12.2027
Class III (implantable devices): 26.05.2026
The sell-off date is to be eliminated. What does that mean?
The sell-off regulation ensures that medical devices that were placed on the market before the MDR came into force or during the transition period from MDD to MDR will continue to be made available until May 2025 and will be withdrawn from the market as of then (stipulated in Article 120(4) of the MDR). These are always products whose safety has already been demonstrated!
This regulation is now to be dropped. This also applies to the IVDs affected by the IVDR. IVDs and medical devices already placed on the market may therefore continue to be sold beyond 2025.
The reasons: Adherence to such a regulation would possibly ensure that safe medical devices would have to be disposed of. The deletion of the sell-off date is also intended to prevent a shortage of the products concerned.
What is changing about the MDR’s usability requirements?.
Nothing! All the articles we have listed and “translated” in the following article still apply: “Deep Dive: MDR and Usability“.
Conclusion
The new transition periods are intended to counter supply bottlenecks and give medical device manufacturers more time to respond to the requirements of the MDR. However, this only applies to devices that have a certificate or declaration of conformity issued before May 26, 2021 (exception: implantable custom devices in Class III).
Other requirements: The medical devices must already be demonstrably safe and the first steps toward conversion to the MDR standard must already have been taken.
The elimination of the sales deadline is intended to prevent supply bottlenecks for certain products and to prevent the disposal of safe medical devices.
Are any of your products affected by the changes? What is your specific case? Comment on this post or get in touch via our contact form. We look forward to hearing from you.
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