BIVDA, as part of a MedTech Europe-led coalition alongside 39 national associations, have sent an open letter to Commissioner Stella Kyriakides asking for action on the medtech regulations (IVDR and MDR) to ensure device availability and competitiveness of the sector for medical technologies.
The letter asks the Commissioner to make reform of these regulations her priority and urge her successor to do the same to solve their ongoing serious implementation challenges. Action is needed to reverse the exodus of innovation from Europe and to prevent further discontinuations of medical technology intended to protect patient safety and public health. The policy suggestions are as follows:
1. A package of legislative reforms for each of the two regulations should be developed to ensure that these regulations deliver on their original objectives.
2. Several ‘bridging measures’ are urgently needed to support device availability and the viability of the medical technology industry.
3. Specific measures to improve the implementation of the regulations should continue to be pursued through existing work streams and tools.
You can read the letter here.
