FAQs | The New In Vitro Diagnostic Device Regulation (IVDR)

The new IVDR, known as (EU) 2017/746, was published on 5 May 2017 by the Official Journal of the European Union. 

As a result, regulatory affairs professionals and device manufacturers are now seeking clarification on how to implement the new requirements within their organisations.

LRQA’s medical device technical experts answer some frequently asked questions ▼