TB 31/19MDR Implementation – Consequences for Notified Bodies and Impact on Medical Device Industry

EIGA has prepared this Technical Bulletin to raise their concerns about the implementation of the new Medical Devices Regulation (MDR) and consequences for all parties involved including Notified Bodies, Medical Device Industry and users.

Medical Device manufacturers are strongly recommended to check the progress of their current Notified Body in becoming notified under MDR and be prepared to identify an alternative Notified Body in the event of a delay in becoming notified under the new regulation.

This Technical Bulletin is intended to be used to assist in any discussions with EIGA Members and Notified Bodies and, the Medical Device Industry and users.