Extension To EU MDR Transition Periods Finalised

• Jurisdiction: European Union
• Law Firm: Arnold & Porter
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Compliance, Biotechnology & Nanotechnology
• Author: Ms Jacqueline Mulryne and Eleri Williams
• Published date: 28 March 2023

With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the 'sell-off' deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.

Background

Stated to be due to the COVID-19 pandemic, in April 2020 the date of full application of the MDR was postponed by one year to 26 May 2021. At that time, the date of 26 May 2024 was maintained as the last date when 'legacy' medical devices could be placed on the market.

As set out in our blog, it has recently been recognised that due to the insufficient capacity of Notified Bodies to enable the conformity assessment of a large number of devices to be undertaken before 26 May 2024, as well as manufacturers not yet being able to demonstrate compliance with the requirements of the MDR, the availability of medical devices was likely to be seriously affected, causing significant disruption to supply chains and to healthcare.

Therefore, as a matter of urgency, it has been necessary to:

• extend the transition periods during which legacy devices that remain in conformity with the old regime can be placed on the market, and
• extend the validity of certificates issued under the previous medical device regime that have already expired, subject to certain conditions.

The new Regulation introduces these changes into the MDR, and extends the length of the transition period applicable to a device. The length of that extension depending on the risk class of the device concerned; the period is shorter for devices falling into a higher risk class, and longer for those devices falling into a lower risk class.

Notably, the Regulation entirely removes the 'sell-off' deadline (previously until 26 May 2025), by when devices already placed on the EU and EEA market could remain in the supply chain, and made available to end users, without having to be...