Europe – MedTech Europe slams EU over lack of preparation for MDR/IVDR

With six months to go before the EU’s new Medical Device Regulation takes effect, Europe’s medtech trade association is accusing government authorities of dragging their feet on the process.

MedTech Europe said that the industry is trying to prepare but that it remains “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 said in a statement released today.

The group acknowledged the increased political attention to the MDR in recent months, as well as efforts by the commission and member states to solve challenges such as the lack of notified bodies to determine whether previously cleared devices comply with the new regulations…