On 20 March 2023, the EU published the Regulation (EU) 2023/607 extending the transition periods for devices requiring a Notified Body for conformity assessment under Regulation (EU) 2017/745 (MDR).
According to the new Regulation, the MDD certificates can be recognised as valid even beyond the dates indicated on the certificate if certain conditions set out in the Regulation are met.
The legacy devices that can benefit from the extended transitional period can be:
- devices which are class I devices under MDD (Directive 93/42/EEC), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
- devices covered by a valid EC certificate issued in accordance with the MDD prior to 26 May 2021. Certificates that have expired before 20 March 2023 can also be considered valid if a national competent authority has granted a derogation in accordance with Article 59(1) MDR.
The extended transition period is:
- until 31 December 2027 for all Class III and for Class IIb implantable devices (except WET devices)
- until 31 Dec. 2028 for all other devices (class IIb devices other than those covered above, class IIa devices, and class Is/Im/Ir devices)
In order to benefit from the extended transition period, the following prerequisites apply:
- the device continues to comply with Directive 93/42/EEC;
- there are no significant changes in the design and intended purpose;
- the device does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- the manufacturer has put in place a quality management system in accordance with MDR by 26 May 2024 at the latest;
- the submission of a formal application to a Notified Body until 26 May 2024 at the latest and the conclusion of a formal written agreement under MDR until 26 September 2024. This agreement should cover the legacy device, or a device intended to substitute that device.
Additional information can be found on the Q&A document issued by the European Commission.
During the transition period appropriate surveillance in respect of the applicable requirements relating to the devices has to be conducted. As of 26 September 2024 at the latest, the surveillance will be carried out by the MDR designated notified body that has signed the written agreement. If this is different than the notified body that issued the MDD certificate, a transfer agreement (‘tripartite agreement’) has to be signed in order to set the arrangements for the transfer of the surveillance.
The terms, conditions and operating processes for the surveillance of legacy devices according to MDR Article 120 are presented in Terms and Conditions for Surveillance of Legacy devices.