EU grants more time to certify medical devices

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EU grants more time to certify medical devices

The European Commission has given manufacturers more time to bring their products into compliance with new EU rules for medical devices. (Image: Paolo Bona/Shutterstock)

BRUSSELS, Belgium: Europe is struggling with the effects of the SARS-CoV-2 pandemic and the war in Ukraine, and the bloc could not have picked a worse time to transition to its overhauled medical device regulation. The European Commission (EC) now wants to give manufacturers more time in order to avoid the real threat of device shortages.

The EC has adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR)—giving manufacturers of medical devices more time to certify their products and bring them into compliance with the new rules. Under the amendments, manufacturers now have at least three more years to have their products certified. The new deadlines are December 2027 for high-risk devices and December 2028 for devices deemed medium or low risk. These extensions apply to devices that are considered “safe” and for which the manufacturers have already taken steps to transition towards gaining certification under the MDR.

Having come into law in 2017, the MDR became applicable in May 2021, after being delayed by one year owing to the global pandemic. A transition period of three years was provided for the MDR and its partner regulation, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), to supersede the existing Council Directive (EEC) 93/42 concerning medical devices (MDD) and Council Directive (EEC) 90/385 on active implantable medical devices (AIMDD). An additional “sell-off” provision in the MDR specified a date after which products already placed on the market and certified under the MDD or AIMDD would have to be withdrawn. The EC has now scrapped that provision, emphasising that essential medical devices that are already on the market should remain available to patients in need.

European Health Commissioner Stella Kyriakides proposed the changes in Brussels in December, citing multiple issues. She said: “A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients.” Admitting that most manufacturers were struggling to meet the certification requirements in the time given, the commission stated in January that the limited progress made posed a threat to device availability. It cited a number of factors, such as the limited capacity of notified bodies (entities that check compliance with medical device regulations), the ongoing effects of the COVID-19 pandemic, global supply chain disruptions and limited preparedness on the part of manufacturers. These factors were “causing a risk of shortages of life-saving medical devices for patients,” the EC said.

The commission stated: “Many manufacturers are not sufficiently prepared to meet the robust requirements of the MDR by the end of the current transition period. This threatens the availability of medical devices on the EU market.”

Figures provided by the EC show lacklustre progress. By October 2022, notified bodies had received just 8,120 applications for MDR certification and fewer than 2,000 certificates had been issued. At that time, a total of 22,793 MDD and AIMDD certificates had been due to expire before the supersession of these regulations by the MDR and IVDR.

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