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Position Category: Technical Regulatory Affairs

Our positions on European standards, trade policies, and radiation protection ensure healthcare technologies remain safe, compliant, and accessible across markets.
May 6, 2026

Towards More Predictable Conformity Assessments in the EU: Statement on Annex VII Implementing Act

COCIR welcomes the adoption of Commission Implementing Regulation (EU) 2026/977 (Annex VII on Notified Bodies’ procedures) as a timely and necessary...
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April 30, 2026

Targeted revision of EU MDR Rule 11 for medical device software

MDR Classification Rule 11 on software has been revised in response to numerous implementation challenges over the past years. In December 2025, the European...
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December 16, 2025

COCIR response to the publication of the Proposal for a Targeted Revision of the Medical Device Regulation

COCIR welcomes the publication of the legislative proposal for a targeted revision of the Medical Devices Regulation (MDR). We thank the European Commission...
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November 5, 2025

Recertification under the MDR and IVDR – Frequently Asked Questions

This document, co-signed with AESGP, eurom, Euromcontact and MedTech Europe, examines the challenges posed by the five-year re-certification requirement under...
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November 4, 2025

Digital label for authorised representative and importer

Together with MedTech Europe, AESGP, and Euromcontact, we call on the European Commission and the co-legislators to allow via the upcoming MDR/IVDR legislative...
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April 29, 2025

Open Letter To European Commission President Ursula Von Der Leyen

The United States is Europe’s most important trading partner for medical technologies. However, recent trade tensions and the threat of tariffs now pose an...
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March 19, 2025

COCIR: Future governance of medical technologies in Europe

In this joint discussion paper, the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM and FIDE, makes the case for...
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March 11, 2025

Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply

This flowchart, co-signed by AESGP, COCIR and MedTech Europe, has been developed to support companies in implementing a structured decision-making process in...
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February 27, 2025

Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body

MedTech Europe, AESGP, MedTech &Pharma Platform and COCIR would like to express their concern that the recently updated MDCG 2019-6: Requirements relating...
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February 17, 2025

European medical technology industry calls for the EU to join the Medical Device Single Audit Program (MDSAP) as a Full Member

MedTech Europe and COCIR call for the European Union (EU) to seek full membership in the Medical Device Single Audit Program by becoming a member of the MDSAP...
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