Regulatory Archives - CAMD : CAMD

Medical Devices and In Vitro Diagnostics Regulations: publication of a consensus statement from the EU Competent Authorities to the EU Commission

By Mina Blaess / On July 26th, 2024 / In Events, Health, Regulatory

National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for medical devices. This consensus statement outlines common priorities for future actions to implement and current challenges to overcome. On...

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Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices (MDR)

By Camd Admin / On June 16th, 2022 / In Health, Regulatory

This Questions and Answers document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale. It considers how certificates of free sale should be processed/ generated for ‘old’, ‘legacy’ and MDR compliant devices. It highlights...

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CAMD Statement – 50th CAMD Plenary meeting

By Camd Admin / On June 10th, 2022 / In Events, Health, Regulatory

In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to MDR and capacity of the medical device system. CAMD recognise the significant and urgent challenges that remain in ensuring sufficient...

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