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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.