Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the application of the new transitional period. With the new provisions, manufacturers and notified bodies will have more time to assess the safety of medical devices certified under the previous Directives.
The Q&A document covers, among others, the following topics:
Scope of the extension of the MDR transitional period
The document specifies that only legacy devices can benefit from the transitional period, namely:
- Class I devices under the Directive, with a declaration of conformity drawn up before 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
- Devices with a valid CE certificate issued under the Directives (MDD and AIMDD).
MDR certificates, custom-made devices, and conditions for expired certificates
Legacy devices with a valid CE certificate in accordance with the MDR can benefit from the extended transitional period. Notably, the issuance of a CE certificate under MDR does not lead to the withdrawn of the previous certificate. Consequently, a legacy device and an MDR certified device can be placed on the market in parallel.
Among the Q&As, it is specified that class III custom-made implantable devices can be placed on the market without the relevant CE certificate until 26 May 2026. However, the same extension requirements apply to custom-made devices: conformity assessment application by 26 May 2024 and signed agreement by 26 September 2024.
Moreover, certificates expired before 20 March 2023 (publication of the new law) are considered valid under the following conditions:
- the manufacturer and a notified body have signed a written agreement for the new certificate before the expiration date;
- a national competent authority has granted a derogation.
The transitional period under these two conditions goes until 31 December 2027 or 31 December 2028, based on the device’s class under the MDR.
Evidence of extended transitional period
Given that the requirements are met (Article 120 of MDR), the extension of the transitional period and certificate’s validity is automatically by law. In certain cases, the manufacturer needs to demonstrate that the expired certificate is still valid, for instance, if the manufacturer wants to access a third market on the basis of EU conformity (e.g., Free Sale Certificates). In such cases, manufacturers should provide a self-declaration confirming that they meet the extension requirements. In particular, this declaration should include:
- End date of the transition period.
- Clear identification of the devices covered by the extension and certificates concerned.
- A confirmation letter from a notified body can provide additional evidence (not mandatory), stating the receipt of the manufacturer’s application for conformity assessment and the existence of a written agreement.
Conditions to be fulfilled to benefit from the extended MDR transition period
To benefit from the extended transition period, the manufacturer and notified body must sign a written agreement no later than 26 September 2024.
Written agreement and application requirements
Overall, the application should include the elements listed in Annexes IX to XI to the MDR as well as a clear identification of the devices and their characteristics. The notified body does not need to receive the technical documentation for each devices to proceed with the agreement. Nonetheless, the written agreement should include a schedule for the submission of the complete documentation, such as the full technical file for each device.
According to Article 120 of the MDR, the manufacturer must have an MDR-compliant QMS, which needs to be part of the application for conformity assessment.
Appropriate surveillance to be performed by notified bodies
As stated in Article 120 of the MDR, there must be an agreement between the manufacturer and the notified body, involving the notified body which previously issued the certificates under the Directives. This agreement addresses the transfer of the appropriate surveillance in respect to devices. The written agreement for the conformity procedure and this transfer agreement can be combined in one agreement if this is more convenient for the parties.
Importantly, the notified body that issued the Directive certificate continues to be responsible for the appropriate surveillance. Alternatively, the manufacturer can agree with an MDR notified body that the latter becomes responsible for the surveillance. However, the MDR notified body that signed the agreement will become responsible for the surveillance at the latest by 26 September 2024.
Deletion of the “Sell-off” date
The devices benefiting from the “sell-off” date removal are devices placed on the market before 26 May 2021 for medical devices and before 26 May 2022 for IVD medical devices. This means that there is no longer an end date from which the devices already on the EU market shall be recalled from the market.
You can find all Commission and other relevant documents in our Library of Documents.