It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the end of the transitional period. After sustained pressure from companies and Member States alike, late last week (on 9 December), the Commission finally confirmed that it intends to extend the transitional period under the MDR. Member States are said to have agreed with the proposals. We set out a summary of what is known so far below.
Challenges with implementation of the MDR
Under the MDR, all medical devices on the market in the EU must be re-certified by May 2024. Further, certificates under the previous regime set out in the Medical Device Directive (MDD) are expiring, meaning that the date when the device must be in compliance with the MDR is in fact shorter for many products. The Commission has stated that there are 22,793 certificates under the MDD that will expire before May 2024, and that do not yet have certificates under the MDR. Given notified body capacity, the speed at which products can obtain certification under the MDR is slow and burdensome. Stella Kyriakides, the Commissioner for Health and Food Safety, stated that “There is a real risk that most of medical devices will expire or not be available in the EU market”.
Therefore, on 9 December, the Commission proposed changes to the legislation (to add to other recent proposed solutions, such as those set out in the MDCG Position paper from August this year, which also tried to address supply disruption issues due to notified body capacity and manufacturers’ preparedness).
The scope of the latest proposals will be set out in the new year. However, the information provided to date indicates the following measures will be introduced:
- an extension of the transitional period under the MDR, with different deadlines depending on the risk classification of the device, as follows:
|Proposed transitional period (precise as yet unclear)
2. “if needed for legal and practical reasons”, the extension of the transitional period could be combined with an extension of the validity of certificates issued under the MDD.
3. Conditions will be set out to enable devices to benefit from the extended periods, for example, that:
- the device does not present any unacceptable risk to health and safety,
- the device has not undergone significant changes in design or intended purpose, and
- the legal manufacturer has already started the process to bring the device into compliance with the MDR (such as submission of the application to a notified body) before a certain deadline (e.g. 26 May 2024).
4. the ‘sell off’ period, by which devices that are on the market can continue to be sold until May 2025, will be repealed to that devices will not need to be recalled or discarded by this date.
In addition, on the same day, the MDCG published a Position paper on the application of Article 97. Under this Article, “the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance” with the MDR. The Position Paper aims to achieve a common understanding of how this Article applies where a device is not in conformity with the MDR because its certificate issued under MDD has expired before issuance of the necessary certificate under the MDR. However, the Position Paper notes that this should be a temporary solution and “should not be regarded as a commonly agreed solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.”
The members of the Council of the European Union strongly supported the proposal to extend the transitional deadlines as proposed by the Commission. The proposed extensions will require an amendment to the MDR, which will need to be approved by the Council and the European Parliament; all stakeholders agree that it should be implemented as soon as possible.
However, this proposal, or what is currently known about it, only goes part of the way. The Commission also has to address the expiry of certificates under the MDD, and despite the wording in (2) above, it is not clear if the proposals will cover this. At present, once a certificate expires, a medical device cannot be placed on the market. An extension to the transitional period is fairly meaningless if the CE certificate has expired in the meantime.
In addition, the proposal is focused on the MDR, and, with the exception to the extension of the sell-off period, it was not expressly stated which of these proposals will also cover the IVDR. It is important that the Commission addresses these devices quickly.