Impact of the new Medical Device Regulation – What are the highlights?

The EU Commission has published a consolidated text of the medical device (MD) and In-Vitro diagnostic device (IVD) regulations in June this year. The new text includes several new requirements that were set in the first line to harmonize and/or enforce and/or increase the requirements on MD and IVD Devices in Europe and on the second line to increase transparency for the commission, member states, notified bodies and final users. During this session, a representative of the biggest notified body in Europe will present the highlights of these regulations and the impact of the changes on the medical device manufacturers and the CE Marking Process.