March 7, 2023
The European Council has unanimously voted in favor of an amendment to extend Medical Devices Regulation (MDR) transition periods for some medical devices. The final step will be publication of the amendment in the Official Journal of the European Union (OJEU), expected on March 15.
Following publication, provisions of the amendment will take effect. These include:
Amendments Article 120(2) MDR
These amendments extend the validity of CE certificates under the Medical Devices Directive (MDD) that were valid on the day of the MDR's date of application (May 26, 2021) and have not been withdrawn by a Notified Body (NB). The extension for certificates expired when the proposed amendment comes into force would be subject to the condition that:
- At the moment of the expiry, the manufacturer has signed a contract with an NB for the conformity assessment of the device in question;
- Alternatively, a national competent authority may have granted a derogation in accordance with MDR Article 59;
- Or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with MDR Article 97.
Amendments to Article 120(3) MDR
These amendments extend transition periods:
- From May 26, 2024 until December 31,2027 for higher-risk devices (Class III and Class IIb implantable devices except for certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well-established technologies)
- From May 26, 2024 until December 31, 2028 for medium and lower-risk devices (other Class IIb devices and Class IIa, Class Im, Is and Ir devices)
NOTE: Cumulative conditions for the application of the extended transition period need to be met:
- The devices must continue to comply with MDD, as applicable;
- The devices do not undergo significant changes in the design and intended purpose;
- The devices do 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 concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR. No systematic check of the device’s safety is required, as devices covered by a certificate issued under the Directives will be under ‘appropriate surveillance’ by the body that issued the certificate or a notified body designated under the MDR;
- No later than May 26, 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR.;
- No later than May 26, 2024, the manufacturer, or its authorised representative, has lodged a formal application in accordance with Annex VII, Section 4.3, of the MDR for conformity assessment in respect of a ‘legacy device’ covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than September 26, 2024 the NB and the manufacturer have signed a written agreement. The devices covered by a certificate issued under the AIMDD or MDD remain subject to "appropriate surveillance" by the NB that issued the certificate. Alternatively, the manufacturer can agree with an NB designated under the MDR that the latter becomes responsible for the surveillance.
The proposal also introduces a transition period of until May 26, 2026 for Class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR.
And last but not least, amendments to Article 120(4) MDR include removal of the current ‘sell-off’ date (May 27, 2025). Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.