In May 2022, the new In-Vitro Diagnostics Regulation became fully applicable in the European Union. This implementation has brought a significant amount of challenges in the requirements to market products on the EU market.
If you are unsure of how you should now proceed in order to import new devices, or maintain the previous ones in the European territory, this webinar is what you were looking for.
Our experts will be discussing:
- Which are the steps to follow;
- How to determine the status/class of your device, and what are the related implications;
- The Authorized Representative’s role in the review process