More on EU Health Commissioner proposed MDR delay

On December 9 the European Union Health Commissioner proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages. If passed into law early in 2023, the amendment will give the EU, manufacturers and notified bodies four to five years to fix the problems that have forced officials to twice delay MDR.

In response to the COVID-19 pandemic, officials modified the original schedule and permitted devices with current certificates issued under the previous regulations to remain on the market until 2024. But as the deadline has drawn nearer, concerns about the EU's capacity to handle the backlog have grown. There is currently a backlog of 23,000 certificates that need to be processed by 36 organizations by May 2024.

What do we know so far:

• Extension of the transition period to 2027 for Class III and IIb, and to 2028 for Class IIa and I
• Extension of validity of MDD and AIMDD certificates to suit the above classification
• Extensions only apply if:
  • No safety signals from PMS data
  • Notified body application for conformity assessment in place before May 2024 and/or
  • QMS certified to MDR by May 2024

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);

In the mean time expect Notified Bodies to continue ongoing MDR certification reviews, Technical file reviews per sampling plan, and scheduled and unannounced audits. As a medical device manufacturer you are still expected to pursue PMS reports to monitor any safety signals and conduct PMCF studies to gather further evidence to support all indications ahead of the new deadlines.

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