Technical Regulatory Affairs Archives - Page 2 of 2

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.

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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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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October 18, 2024

Urgent measures needed to ensure the availability of medical technologies in Europe

COCIR welcomes the attention raised by the European Parliament on the shortcomings in the implementation of the Medical Devices Regulation. While a thorough...

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September 11, 2024

COCIR Position On The Future Governance Framework For The Medical Technologies Sector

COCIR advocates structural reform of the regulatory and policy framework governing the medical devices sector in Europe to address the root causes of the...

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March 7, 2023

COCIR Statement – Adoption of the EU Medical Devices Regulations extended transitional provisions

COCIR welcomes the adoption of the extended transitional provisions for Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro...

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October 4, 2021

Joint industry statement: Priorities for the Machinery Products Regulation

The Machinery Directive is unquestionably the single most important piece of legislation for the European manufacturing industry. Since its original...