Module 19 2021

01/06/2021

Standards

In the EU, a number of standards are recognised under the IVDD (harmonised standards). (EN standards) To date, no standards have been recognised as “harmonised” under the EU Regulation. (WIP) Be aware that IMDRF learned that while all its member regions use standards for regulatory purposes, they differ in ● how they apply them ● How to recognize them And that there are very few common consensus standards. What is recognised in one jurisdiction may not be in the next.

21

How can we drive harmonisation?

Be aware that good regulation is based on a knowledge of how high a bar should be set. This should be based on identified standards for safety, quality and performance, and of what is implementable and enforceable. Good regulatory practice takes into account all its stakeholders including industry.

22

11