Europe’s medical device trade group is again warning the European Commission that its new Medical Device Regulation (MDR) system will not be ready by its 2020 deadline and that E.U. medtech companies are taking their business elsewhere as a result.
In an open letter to Jyrki Katainen, the commission’s vice president for jobs, growth, investment and competitiveness, MedTech Europe said it is concerned about the designation and capacity of notified bodies, which the European Commission and E.U. member states are still assessing. A notified body is an organization designated by an E.U. country to assess the conformity of certain products before they can be placed on the market.
“It is only after being designated that Notified Bodies will be able to start re-certifying and certifying products to the MDR,” the trade group’s letter said. “Notified Bodies will typically take 3-9 months to complete a product re-certification, and it is expected that it will take them even more time for new MDR certification. Tens of thousands of medical devices will have to undergo such a process, and May 2020 is 13 months away.”
Many product categories representing tens of thousands more devices will be brought under notified body supervision for the first time and will require MDR certification before they can continue to be used, MedTech Europe said.
“At the current pace of preparation, the new regulatory system will not be ready early enough to absorb this extra workload,” the letter said. “As of May 2020, thousands of medical devices will become non-compliant and will not be authorized for use by surgeons, doctors, hospitals and patients.”
A backlog of existing medical devices needing certification under MDR will delay the certification process for new devices, the group added. European medtech startups and small and medium-sized companies, which represent 95% of the E.U. medical device industry, are already turning to the United States, China and other regions to develop and launch their products, it said.
Only one of the 58 existing notified bodies has been designated to operate under MDR, and that one is located in the United Kingdom, which may have left the E.U. by May 2020 under Brexit. The commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) expects that only 12 notified bodies will be designated by the end of 2020, the trade group noted.
“This is way too late, insufficient and gives no guarantee that Notified Bodies would have enough capacity to ensure continued regulatory approval of devices by May 2020,” despite a grace period and a “warehousing clause,” which MedTech Europe said will work for only a portion of the currently available devices.
“This situation is clearly untenable, and time has run out to build a functioning regulatory system,” the group concluded. “The industry continues to support the implementation of the new regulation as a major step to guarantee patient safety and access to innovative medical solutions to alleviate health conditions in Europe.”
The group asked for a meeting to discuss the matter. The commission issued its most recent MDR implementation plan updates in February.