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Dirk Dusharme @ Quality Digest

Standards

European Commission Proposes Extending MDR Deadlines

Puts patient safety first

Published: Friday, December 9, 2022 - 15:47

Updated 12/12/22

At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On the table will be the possibility to extend the deadline to 2027 for higher-risk devices and 2028 for lower-risk devices. 

The European Commission had come under increasing pressure to extend the deadline after EU member states, notified bodies, and medical device companies told the commission that it would be impossible for all medical devices currently approved under the old medical device regulations to transition to the newer regulations by the May 2024 deadline. This was something the Commission’s own studies were bearing out.

This is good news for the medical device community and the EU healthcare system. 

“I think it is apparent that the ministers of health at the EPSCO Council meeting recognized the urgent and serious implementation challenges of the EU Medical Devices Regulation and the impact on availability of medical devices and quality of care for European patients,” says Joe Gatewood, vice president of global strategy at AdvaMed, the world’s largest medical technology association. “The next step is for the European Commission to draft a proposal specifying how they will amend the regulation. Once the proposed amendments are available, our industry will assess if they address the critical implementation challenges at stake for an efficient and successful transition.”

At the Dec. 9 meeting, health ministers from more than 20 EU states repeated their concern that without some sort of action there would be medical device shortages in their countries that would affect patient health and safety

In his opening statement, Vlastimil Válek, deputy prime minister and minister for health of the Czech Republic, noted that by the May 25, 2024, deadline, tens of thousands of medical devices will need to certified, but the capacity of the notified bodies doesn’t support getting that done on time. 

“There is a real risk that most of these medical devices will expire or else they will not be available in the EU market,” said Válek. “And that would impact directly the accessibility of healthcare or its continuity. The safety of patients is now directly threatened, and we need to take corrective steps as soon as possible.”

About 23,000 certificates issued under the old medical devices directives (MDD) have yet to transition to the MDR. This represents hundreds of thousands of devices, according to MedTech Europe. Even by implementing the 19 contingencies outlined by the Medical Device Coordination Group (MDCG) in October 2022, there is no chance that number will be substantially reduced. 

“We are facing a risk of shortages of lifesaving medical devices for patients,” Stella Kyriakides, the EU commissioner for health and food safety, told the council. “This is a risk we cannot take.”

To address the risk, Kyriakides announced that the commission has proposed a targeted amendment of the MDR and IVDR, which could include the following:
• An extension of the transition period with staggered deadlines based on the risk class of the device. For higher-risk class III and class IIb devices, the deadline would be 2027. For lower-risk class IIa and class I devices, those that need notified body involvement, the deadline would be 2028.
• The extension would apply only to devices already deemed safe and that have not undergone significant changes in design or intended purpose. In addition, the manufacturers must have already taken steps toward certification under the MDR.
• Removing the “sell off” provision that would have required that by certain dates, devices already approved under the old MDD and in the hands of distributors would have to be removed. Lifting the provision would prevent safe medical devices that are already on the market from having to be discarded.

Extending the deadline is a positive move, say experts, and will give legacy device manufacturers more time to get certified.

“In my opinion, manufacturers should already have their documentation transitioned to the MDR,” says Kenneth Shaw, director at Specculo Limited, which specializes in medical device regulation. “The main stumbling block has been notified body availability. We’ll have to see the actual proposal and the fine print terms and conditions to comment on the effect it will have on industry.”

Kyriakides says the MDCG will release a position paper early in 2023 that will outline the proposals.

Discuss

About The Author

Dirk Dusharme @ Quality Digest’s picture

Dirk Dusharme @ Quality Digest

Dirk Dusharme is Quality Digest’s editor in chief.