Targeted revision of EU MDR Rule 11 for medical device software
COCIR Position Paper EU MDR Targeted Revision Classification Rule 11_FINALMDR Classification Rule 11 on software has been revised in response to numerous...
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.
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...
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...
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...
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...
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...
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...
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...
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...
November 29, 2024
Medical Technology Industry stands ready to support work on the future of the Medical Technology Frameworks
The availability of medical technologies – both IVDs and medical devices – to patients in Europe is at stake and therefore broad and comprehensive reforms are...
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