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.