Published 22nd March 2023
Regulation (EU) 2023/607 of 15 March 2023 was published in the Official Journal of the European Union on 20 March 2023, extending the validity of certificates for legacy medical devices. The proposal for this amendment was first put forward to ensure that there was no disruption to supply of life-saving products in the EU. It aimed to address Notified Body capacity issues as well as manufacturer readiness for the Medical Device Regulation (MDR). The amendment has also served to axe the sell-off provision for existing products under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
A legacy medical device is one that was certified under the Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD), where the certificate was valid on 26 May 2021. The certificate may have expired prior to 20 March 2023 or may be due to expire prior to 26 May 2024 but must not have been suspended or withdrawn.
Manufacturers of legacy devices that are safe and those manufacturers who have taken steps to transition towards compliance with the EU Medical Device Regulation (MDR) can benefit from the amendment. This extension does not apply to certificates that have been suspended or withdrawn.
For devices with a valid certificate on 26 May 2021 which have not been withdrawn or for those that expired before 20 March 2023, compliance with the Medical Device Regulation (MDR) requirements are required by the following dates:
Regulation (EU) 2023/607 amends Article 120 of the Medical Device Regulation (MDR) to remove the sell-off period of medical devices lawfully placed onto the market prior to 26 May 2021 and those placed on the market from 26 May 2021 under the extended provisions explained in this article. This means that there is no time limit by which such devices will need to be taken out of service.
Regulation (EU) 2023/607 amends Article 110 of the In Vitro Diagnostic Regulation (IVDR) to remove the sell-off period of in vitro diagnostic medical devices lawfully placed onto the market prior to 26 May 2022. This means that there is no time limit by which such devices will need to be taken out of service.
The In Vitro Diagnostic Regulation (IVDR) transition provisions were amended in January 2022 by Regulation (EU) 2022/112.
While the extension to the transitional provisions is a welcome step, manufacturers must pro-actively work towards Medical Device Regulation (MDR) compliance without delay. The extension provisions should only be used as a last resort if efforts for MDR compliance have been unsuccessful. These extended transition periods only apply under certain conditions requiring the complexity of compliance with both the MDD and aspects of the Medical Device Regulation (MDR). Continuing work on MDR transition will provide your customers with the guarantee of supply of your devices on the EU market and will ensure that you secure your position in the queue with a Notified Body sooner rather than later.
Find out how this change may effect you by contacting DLRC’s medical device experts via the links below, or email us at firstname.lastname@example.org.