In Vitro Diagnostic Regulation (IVDR )
A Revolutionary Change in Europe ! Prepare now to be ready in May 2022
How does this change affect me?
If you develop, manufacture or market an In Vitro Diagnostic (IVD) product, your product must be certified by a notified body (NB) by May 2022 or you will not be able to sell in Europe!
If your IVD product is already certified by an NB, it must be recertified under the new requirements by May 2024 after that no “grace period”!
What does recertification involve?
The changes are major, requiring new classification and regulatory strategy.
How can I prepare for this change?
You are just in time! To stay in business, start now with a gap analysis & a work plan.
HaMaDa’s regulatory experts can help you navigate this process.
We handle the bureaucracy so you can focus on the product.
IVDR Roadmap and Deadlines for CE Certification