What are Common Specifications under EU MDR & IVDR?

Medical Device made Easy Podcast · Nov 9, 2020

What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan Bolleininger. In the EU MDR and IVDR, Common Specification is mentioned and it is a tool that the EU Commission can use.

But are you obliged to use them? In this episode, we will talk about a few common specifications. 1 published, 1 under draft, and some that are supposedly planned.

And we can see also that some of the provisions of the EU MDR cannot be applied without the publication of some common specifications.

So even if you think you are…