Source: European Parliament
Priority question for written answer P-002033/2025
to the Commission
Rule 144
Jaroslava Pokorná Jermanová (PfE), Nikola Bartůšek (PfE), Jaroslav Bžoch (PfE), Jan-Peter Warnke (NI), Ondřej Knotek (PfE), Filip Turek (PfE), Kateřina Konečná (NI), Klara Dostalova (PfE), Gerolf Annemans (PfE)
We are writing to express our concern about the unequal access to European markets for medical device manufacturers from different EU countries. Despite the new Medical Device Regulation (MDR), the situation remains unclear. Even if a product is compliant with the MDR, manufacturers cannot be certain that market entry will be stable or straightforward, as each country’s local authority interprets requirements differently.
This could lead to severe consequences, such as shortages of medical devices across EU markets and instability in the healthcare sector. It may also force EU manufacturers out of business, making Europe less self-sufficient and competitive in this strategic sector.
We therefore ask the Commission:
- 1.What is its assessment of the MDR, as it seems to impose substantial demands without providing clear benefits for manufacturers?
- 2.Is there a mechanism that can be used to standardise procedures across Member States to ensure uniformity in their interpretation of the MDR?
- 3.Does it view medical device production as a strategic sector and is there a long-term plan in place for this industry?
Supporters[1]
Submitted: 21.5.2025
- [1] This question is supported by Members other than the authors: Diana Iovanovici Şoşoacă (NI), Aurelijus Veryga (ECR)