As MEPs gathered for the final plenary session of their term at the end of April, they signed off on a file that will give the medical device industry a breather. The lawmakers finalised an extension to the In-Vitro Diagnostics Regulation, more commonly known as IVDR, giving medical device manufacturers, as well as member states’ compliance infrastructure, more time to get their ducks in a row. It is yet another extension to the EU’s updated rulebooks for medical devices. The IVDR and its sister regulation the Medical Device Regulation (MDR) have been in gestation since the 2010s but have seen…

Special Six Nations offer

Become an annual member today for €200 and receive a free copy of ‘From Rags to Riches; The Irish Men’s Team in the Professional Era’ by Feargal O’Rourke

Subscribe

Cancel at any time.

Are you already a member? .