The Council of the EU is expected to vote Tuesday on an extension of deadlines for complying with Europe’s Medical Device Regulation (MDR), in a move to keep critical treatments on the market during the transition period.
The revised timeline would give notified bodies that certify devices in the European Union longer to prepare for the new regulatory framework.
Companies that operate in the European market were expected to have devices recertified by May 2024 under the regulation, but with the deadline approaching, notified bodies faced a backlog, prompting the European Commission to propose extending the time frame.
“Industry is relieved that these amendments have been introduced – they are the culmination of many warning signs about a potential shortage of medical devices in the EU,” Brussels-based life sciences lawyer Josefine Sommer, a partner at Sidley Austin, wrote in an email.
The extension would stagger deadlines until 2027 or 2028, based on device risk classification, allowing manufacturers and notified bodies more time to complete conformity assessments. Products placed on the market under the predecessor Medical Devices Directive (MDD) could remain, under certain conditions.
“Once the amendments have been adopted, it will be interesting to see how the conditions for benefiting from the additional transitional periods are to be interpreted and implemented in practice,” Sommer said.
The upcoming European Council vote follows the European Parliament’s approval last month of the new timetable. EU procedure calls for both branches of the legislature to approve the plan.
“This will be the final step in the process,” an EU official said in an email.
Member state health ministers in the EU’s Employment, Social Policy, Health and Consumer Affairs Council backed the plan in December, after European medical societies called for urgent action to address device supply shortages reported by physicians.
“The Health Council supported the European Commission’s proposal to delay the transitional deadlines to avoid causing harm to EU health systems and, most critically, patient care,” London-based attorney Lincoln Tsang, partner and head of Ropes & Gray’s European life sciences practice, wrote in an email.
The MDR was adopted in 2017 following the recalls of breast implants and metal hip replacements due to safety problems. The regulation tightens controls for the safety and performance of medical devices and includes stricter monitoring and certification procedures to ensure compliance and traceability. The new rules also are intended to reflect technological and scientific advancements in the sector.
With the extended deadlines, higher-risk devices such as implants must transition to the new requirements by December 2027, and medium- to lower-risk devices such as syringes or reusable surgical instruments have until December 2028.
But Erik Vollebregt, a founding partner of Axon Lawyers in Amsterdam, said the timeline still requires manufacturers to be MDR-ready, “with an MDR application in the door at a notified body” no later than May 26, 2024.
“The current state of the market is that everybody is still figuring out what the proposal will mean for them specifically, both industry and notified bodies. Some manufacturers have seen 2027 and 2028 as dates and do not understand that these are dates for notified bodies and not for manufacturers,” Vollebregt said in an email.
Reuters reported in December that medical device manufacturers were dropping products from their European portfolios because of the cost of complying with the new regulations.
Although six new notified bodies received MDR designation in the second half of last year, it created a pool of 36 organizations to process around 23,000 certificates of current devices on the market, prompting EU Health Commissioner Stella Kyriakides to propose delaying enforcement of the MDR.