Published on:
16. April 2025

Common Pitfalls in IVDR Submissions

At our February information sessions on the transition from the IVDD to the IVDR, we had in-depth discussions about common errors in the submission of technical documentation. Many manufacturers face similar challenges – which is why we, as a Notified Body, have now published the most frequent non-conformities on our website.

What can you expect?

  • An overview of typical errors in the submission of technical documentation
  • Practical guidance on how to avoid common pitfalls
  • All information compiled in a single downloadable document
Please note: These examples are provided for illustrative purposes only and do not constitute formal guidance.

 

 

We hope this compilation helps manufacturers avoid common stumbling blocks and streamline their IVDR documentation efforts.