Europe – Winding down to the EU IVD and Medical Devices Regulations Deadlines: The Finish Lines in Sight?

Today marks the half-way point of the EU IVD Regulation’s (IVDR) five-year transition period and the start of the final six months to the EU Medical Devices Regulation’s (MDR) date of application.

The medical technology industry shares the Regulations’ goals of patient safety and transparency and remains committed to doing all it can to comply with the new rules in due time.

However, despite the industry’s efforts to get ready, we remain seriously held back by the slow and piecemeal implementation of the new regulatory framework.

As we have maintained throughout the Regulations’ transition periods to-date, this incomplete implementation by the EU Member States and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies.

MedTech Europe recognises and welcomes the increased political attention to the MDR in recent months, and the efforts of the European Commission and Member States to find solutions to that Regulation’s transition challenges, especially the low availability and capacity of Notified Bodies…