Public Consultation on EU MDR and IVDR Effectiveness

The European Commission has launched a public consultation to evaluate the effectiveness of the EU Medical Device Regulation (EU MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746) over the period from 2017 to 2024.

Objective: Evaluating the Effectiveness of EU MDR and IVDR

The aim of the consultation is to gather feedback on the regulations’:

• • Effectiveness
  • Efficiency
  • Relevance
  • Coherence
  • EU added value

Target Audience for the EU MDR and IVDR Consultation

The consultation seeks input from a wide range of stakeholders, including:

• • EU Member States/EEA competent authorities
  • Notified bodies
  • Economic operators and associations
  • Healthcare professionals and associations
  • General public, patients, and consumers
  • Civil society organizations
  • Academic and research experts
  • Regulatory affairs experts
  • European bodies and international organizations

How to Participate in the EU MDR and IVDR Evaluation

Stakeholders can contribute by filling out an online questionnaire available in multiple EU languages. The consultation period runs from December 12, 2024, to March 21, 2025.

Full article: EU rules on medical devices and in vitro diagnostics – targeted evaluation

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