The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.
In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing. We hope you find it insightful. For questions, please contact info@criterionedge.com.
ABOUT
