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EU Health Commissioner proposes MDR delay to prevent medical device shortages

The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages.

European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR). Members said they are concerned there isn’t enough capacity to handle all the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires and fear the current deadlines could trigger widespread shortages if left in place.

Stella Kyriakides, the European health commissioner, proposed postponing the MDR transitional deadlines during a 9 December session of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels. She urged the Council and the European Parliament to extend the deadline for higher risk class III and class IIb devices to 2027 and the deadline for lower risk class I and class IIa devices to 2028.

“The transition to the new rules has been slower than we anticipated,” she said. “The pandemic, shortages of raw materials caused by the Russian invasion against Ukraine and low notified body capacity has put a strain on market readiness.”

Kyriakides noted that there has been recent progress toward the new framework, including an increase in the number of notified bodies designated for medical devices from 30 in June 2022 to 36. The number of notified bodies designated under IVDR currently stands at eight.

Below the plan that the EU Commission will present during the EPSCO Health Council on 9th December:

  • An extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment;

  • If needed for legal and practical reasons (including for access to third country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR;

  • Conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024);

  • The removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR.

Now, we need to wait a little bit more to figure out the final resolution!

EU MDR extension
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Source: Routers

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