EU Commission's adoption regarding the proposal to extend the current transition period in MDR Article 120 related to ‘legacy devices'

On the 6th of January 2023, The European Commission adopted a proposal to allow medical device manufacturers already certified under Directive 93/42/EEC more time to certify their products under the (EU) 2017/745 (MDR). The proposal would also repeal the “sell-off” date provision under MDR. This adoption from the European commission was made amid concerns of a potential shortage of lifesaving products. The proposal now moves to the European Parliament and Council for adoption into law, as this proposal is yet to be approved.

In short, under the proposal, if this comes into force this will mean that the transition period deadline would be extended from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device. High-risk devices would be subject to the shorter transition period ending in 2027, while low- and medium-risk devices would have until the end of 2028 to complete a conformity assessment.

The application of the extended transition period is subject to several conditions, such as:

The devices must continue to comply with Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR.
The devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR.
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 later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements.
No later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application under the MDR.
No later than 26 September 2024 the notified body and the manufacturer have signed a written agreement.

Expired Certificates

As regards to certificates that have already expired when, and if, the proposed amendment comes into force, the extension would be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question. Alternatively, if no such contract has been signed at the moment when the certificate expired, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.

Guidance to assist in the application of MDR article 97: MDCG 2022-18 position paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.

Deletion of the sell-off date provision

Regarding the deletion of the sell-off date provision, the measure will reduce the risk of shortages by allowing devices that were already on the market based on compliance with the directives to remain on the market. The provision would not allow devices with a limited shelf-life to be offered past expiry.

Please find all details in the proposal for a Regulation amending Regulation (EU) 2017/745 on the EU commission website: health.ec.europa.eu

Useful Resources

More information on the Medical Devices Regulation can be found below:

Please note:

If you are a client and have a current MDD certificate(s) with us, these will remain under SEMKO AB NB 0413 until that certificate expires, unless you are specifically notified otherwise.