European Commission’s proposal to extend the transitional periods of the medical devices Regulation has been approved by the European Parliament

The European Commission’s proposal for an amending Regulation on the staggered extension of transitional periods for medical devices has been approved at the European Parliament’s plenary sitting on 16 February 2023. The amending Regulation enters into force once it has been published in the Official Journal of the European Union. It has been estimated that the amending Regulation could enter into force in approximately a week.

The extension of the transitional periods only applies to medical devices placed on the market before 26 May 2021. Depending on the risk class, the extension of the transitional period lasts until 2026–2028. Risk class I medical devices of the MD Regulation do not have a transitional period, except when they need an assessment by a notified body. One of the main reasons for the amending Regulation was the limited availability of notified bodies. In addition, the amending Regulation removes the sell-off date restriction provided under both the MD Regulation and the IVD Regulation.

In order for a medical device manufacturer to take advantage of the extended transitional period offered by the amending Regulation, certain conditions must be met. These conditions include:

• the devices continue to comply with the MD Directive and the AIMD Directive
• no significant changes have been made to the design or intended purpose of the devices
• the devices do not present a risk to the health or safety of patients
• the manufacturer has put in place a quality management system in accordance with the MD Regulation no later than 26 May 2024
• the manufacturer has lodged a formal application for conformity assessment with a notified body in accordance with the MD Regulation within the time limits specified in the amending Regulation

The new staggered, extended transitional periods for medical devices of different risk classes and their conditions are described in the proposed amending Regulation, the different language versions of which have been published in EUR-Lex.

Read more:

Amending Regulation (all official languages): EUR-Lex - 52023PC0010 - EN - EUR-Lex (europa.eu)

Fact sheet: European Health Union: Supporting the transition to the new medical device framework 

Commission note of 26 January 2023

Fimea news item 11/01/2023: Commission proposes extension for certification period for medical devices in accordance with MDR - Fimea.fi - Fimea

European Commission press release 6 January 2023 Public health: more time to certify medical devices to mitigate risks of shortages (europa.eu)

MD Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

IVD Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices