Extended transition period for MDR

The EU has adopted a regulation extending the transition period for medical devices certified under old EU rules. The amendment aims to ensure continued availability of medical devices and to protect patient safety. However, this is subject to a number of conditions.

Risk class determines length of transition period
Briefly, the changes mean that devices certified under the MDD or AIMDD (classes Im, Is, IIa, IIb and III) can continue to be released onto the market until 31 December 2027 or 2028, depending on the risk class.

Devices classified up to a higher risk class under the MDR and requiring a certificate under the MDR can be released up to and including 31 December 2028.

Devices that can benefit from the extended transitional period
Only ‘legacy devices’ can benefit from the extended transitional period. These are devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled. Those devices can be:

• devices which are class I devices under Directive 93/42/EEC (MDD), 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 Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.

It should be noted that if the validity of certificates under the MDD or AIMDD had expired before 20 March 2023, an agreement with a notified body or a waiver from an authority is required to extend the validity and make use of the transition periods.

Application to notified body
To benefit from the from the extended transition period a formal application to the notified body must be made by 26 May 2024 and an agreement must be established by 26 September 2024. There is also a requirement to have a quality management system in place by the former date.

Previously established requirements for the transition period apply
The devices must continue to fulfil the requirements of the MDD or AIMMD. They must not present an unacceptable risk and no substantial changes may be made to the devices. They are subject to the MDR requirements for device registration, market surveillance, vigilance and market control.

End date removed
The end date, or ‘sell-off’ date, for the supply and putting into use of devices at the distribution and user stage is being removed from both the MDR and the IVDR. This applies to devices that have been legally released on the market prior to the application date for the MDR (26 May 2021) and the IVDR (26 May 2022), and devices that have been released according to the respective regulation’s transition rules.

Future
The medical device industry has long warned that devices risk disappearing from the market once certificates have expired, and there are long waiting times for notified bodies, which are still too few in number.

Setterwalls notes that the changes offer some respite to companies on the matter of existing devices. However, it does not change anything for completely new devices that must fulfil the requirements of the MDR in order to be placed on the market. We will continue to monitor the situation closely.