In May 2016, the EU finally reached an agreement on updates to the overarching regulations for medical devices and in vitro diagnostics that haven’t been updated since the 1990s.
Join the European Diagnostic Clusters Alliance (EDCA) and their members for a conference featuring updates of the upcoming regulations with access to European experts and notified bodies.
The regulation is expected to tighten the regulation and surveillance of notified bodies, the independent entities responsible for assessing medical devices before they can be marketed. The new regulations will also give notified bodies the right to carry out unannounced device manufacturing facility inspections and manufacturers will be responsible for tracking the quality, performance and safety of devices. The draft regulations also improve the availability of clinical data on devices and strengthen the protection of patients participating in device trials. Also included is a proposal to create a Medical Device Coordination Group comprised of national representatives that will double check assessments of high-risk devices carried out by notified bodies before the devices are placed on the market. The new EU rules also explicitly cover certain devices without a medical purpose but with similar characteristics as medical devices, including fillers and coloured contact lenses.
Don’t miss the chance also to arrange B2B meetings with cluster member companies by participating in the matchmaking event organised with Enterprise Europe Network!
This B2B event aims to initiate R&D, technological and commercial collaborations between organizations from different countries in diagnostics and affiliated sectors, with one-to-one 20-minutes pre-scheduled meetings. Please note that the bookings are managed on the principle "first come - first served" basis, and the priority is given to international B2B meetings.
Regulatory challenges - Presentation of the latest updates and panel discussion about the new EU regulations by European Commission experts and/or notified bodies
Pitch presentations from European diagnostics cluster companies
Presentation by EDCA clusters of their ecosystem and strengths in diagnostics
Matchmaking, transnational & transdisciplinary B2B meetings
Free of charge.
|Registration||1 Jun – 16 Sep|
|Meeting Selection||1 Jul – 19 Sep|
|Venue||Bourse de commerce de Paris - CCIP|