Background

Last December the Commission opened a public consultation to evaluate the effectiveness, efficiency, relevance, and added value of the MDR and IVDR. That consultation ran from 12 December 2024 – 21 March 2025.

The above was in response to the challenges implementing the MDR and IVDR (e.g., multiple postponements, EUDAMED delayed), rising costs to comply, and potential reduction of devices available on the European market.

The concerns were enough to bring attention to the Parliamentary level.

Overview of Summary Report

The Commission has published a report summarizing the open consultation feedback: HERE

Overall, 332 responses were submitted. Most respondents were from the EU (86%). And 45% of responses came from economic operators, of which 59 were large-sized companies (250+ employees), 43 were medium (50-250 employees), 32 were small (10-50 employees) and 17 were micro (less than 10 employees).

Respondent perceptions around the MDR

Question	Percentage in Agreement
Has contributed to protecting the health of patients	46%
Has contributed to the competitiveness of the medical device sector	5%
Has contributed to achieving traceability of devices in the EU	39%
Costs for Phase 1 activities are acceptable (e.g., safety and performance data, clinical data, QMS implementation)	6%
Costs for Phase 2 activities are acceptable (e.g., initial certification and the maintenance of certificates)	4%
Costs for Phase 3 activities are acceptable (e.g., post-market obligations, vigilance)	Agreement ranging from 7% to 13%
Costs for Phase 4 activities are acceptable (e.g., providing information on devices or certificates)	Agreement ranging from 10% to 15%

Respondent perceptions around the IVDR

Question	Percentage in Agreement
Has contributed to protecting the health of patients and users	44%
Has contributed to the competitiveness of the IVD device sector	8%
Has contributed to achieving traceability of IVD devices in the EU	23%
Costs for Phase 1 activities are acceptable (e.g., safety and performance data, clinical data, QMS implementation)	10% or less
Costs for Phase 2 activities are acceptable (e.g., initial certification and the maintenance of certificates)	10% or less
Costs for Phase 3 activities are acceptable (e.g., post-market obligations, vigilance)	10% or less
Costs for Phase 4 activities are acceptable (e.g., providing information on devices or certificates)	10% or less

What’s Next?

As noted in the Commission’s Have Your Say webpage and in its December 2024 presentation, the Commission will assess the feedback (along with other factors) and adopt changes in Q4 2025.