At a meeting in Brussels dated Dec 9th 2022, the EPSCO proposed an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
About 23,000 certificates issued under the old medical devices directives (MDD) have yet to transition to the MDR. Even by implementing the 19 contingencies outlined by the Medical Device Coordination Group (MDCG) in October 2022, there is no chance that number will be substantially reduced by May 2024.
EU commissioner Stella Kyriakides reflected strongly on the lack of lifesaving medical devices and the risk it can cause to patients. These concerns are well supported by all member states, notified bodies, and medical device industries.
The EU Commission is now under grave pressure to propose amendments on how they will cater to this concern.
To address the risk, Stella announced that the commission has proposed a targeted amendment of the MDR and IVDR, which could include the following based on the input received so far from national experts and stakeholders
To find more information on the Extension of EU MDR you can refer to the below links
In lieu of this discussion, multiple clients have approached us with a multitude of doubts and confusion, and to address them, we have prepared FAQs that have been answered based on our understanding and experience:
1. Are the transition timelines applicable to all medical device manufacturers?
Answer: No, the extended timelines apply only for legacy device holders, i.e., products that have already been certified under the former directives (MDD) and are due expiry on or before 26th May 2024, owing to the end of the transition period.
2. What do first-time applicants have to do to start selling in Europe?
Answer: Unfortunately, the current proposal does not talk about the new applications under the MDR and IVDR, and the manufacturers will have to prepare their technical documentation proactively, show conformity to the regulation and put down their applications to notified bodies and await their approval to be eligible to sell their devices in Europe. These timelines do not apply to them, and they might have to compete far more as priority will be given to legacy device assessments.
3. What about devices that were earlier self-declared and have now been up-classified or the IVD devices which were earlier not regulated and have now been brought under the regulation and assigned higher risk classification?
Answer: Unfortunately, the transition timelines for such MDs and IVDs expired in May 2021 and May 2022, respectively. Hence, they must comply with the new regulation to continue selling in the EU. This transition timeline extension will not apply to such devices, and they must be brought to immediate conformity with the regulations.
4. What does sell-off mean? What is the proposed change for this?
Answer: The sell-off period indicated in the EU MDR and IVDR was a deadline for devices lawfully placed in the market under the former directives, MDD and IVDD, to be placed in the Market. This was set on 26th May 2025, post which these devices cannot be legally placed on the market. The proposed changes also insist EU remove this “sell-off” provision from Article 120 of EU MDR and Article 110 of EU IVDR so that the device can continue to be placed on the market beyond 26th May 2025.
5. What will be the best strategy to demonstrate continued compliance and take benefit of these extension timelines?
Answer: All said and done, even after the proposal acceptance of extension timelines, it has been clearly stated that to take advantage of this, a medical device manufacturer must have to demonstrate that they have made a relevant effort to transition to the new regulation and have integrated the requirements in their current Quality Management System and performed an adequate gap assessment on their current technical documentation and updated them to requirements of EU MDR. Furthermore, they must have their applications submitted and/or accepted for conformity assessment by the notified bodies before May 2024.
We must all await the final proposal from the EU commission, which is anticipated to be released beginning next year, to further conclude on the validity of our current certification; nevertheless, our efforts to comply with the new regulation should continue. We must update our Quality Management Systems with the requirements mentioned in the regulation and simultaneously perform gap assessments of our technical documentation as these are the pre-requisites to avail this benefit and will be verified by notified bodies in the subsequent surveillance audits or whenever we apply to them for extensions of our current certificate validity.
You can refer to the following links for more information on how to prepare your technical files as per the requirements of EU MDR and EU IVDR.
Author: Khushboo Chhajer
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