Feedback to the MDR and IVDR regulations
The European Commission opened the Call for Evidence for the medical device regulations (MDR and IVDR). HealthTech Finland sent the attached document to the Commission.
We would like to thank for our member companies for their input on this matter.
The performance and safety of medical devices (MD) and in vitro diagnostics medical devices (IVD) is crucial to European patients. However, also the availability of devices to patients is a critical part of high-quality care and patient safety. The healthcare sector is also an important pillar of the EU economy, forming a significant part of EU exports.
HealthTech Finland emphasised that although this call for evidence targets the MDR/IVDR particularly, EU legislation affecting medical device/IVD manufacturers should be considered as a whole.
It is important that the MDR and IVDR are developed further, to incorporate more proportionality into the system, so oversight is better matched with device risks, taking into account recent advances in healthcare, such as digitalisation and AI.
In our feedback, we emphasised the importance of the MDR and IVDR more effectively recognizing the different types and sizes of manufacturers, as well as the various phases of the product lifecycle. The regulations should provide plausible paths to market for startups with their first product, SMEs and established large players and for both truly novel applications technologies as well as established technologies and device types.
HealthTech Finland brought to the Commission its observations and the experiences of its member companies regarding the current MD/IVD regulations, proposed targeted suggestions for more efficient, proportionate legislation, without compromising patient safety.
The feedback period expired on 06.10.2025. Commission received in total 441 feedbacks.
Healthtech Finland: Feedback from: HealthTech Finland
Cocir: Feedback from: European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry (COCIR)
