Knowledge Bites, Part 4: Post market surveillance will now require periodic updates

28-03-2017

Author: Colin Kavanagh and Ciara Farrell



The new EU Medical Device Regulations, which are due to be voted on by the European Parliament,  will result in increased post market surveillance and vigilance requirements for medical device manufacturers. One of the new requirements in the field of vigilance reporting is the periodic safety update report (PSUR).

Manufacturers of class IIa, IIb and III devices along with manufacturers of class C and D IVD devices will now need to complete and maintain a PSUR for each device or category/group of devices that they manufacture. Companies must now be prepared to update their technical file to include PSURs.

Read the full briefing here.

 

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