Skip to main content
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024)

MedTech Europe are conducting a survey for Europe based users of Near-Patient Testing devices (e.g. Medical Doctors, Physicians, Nursing staff, Operators, Pharmacy staff, Emergency Room staff, Ambulance staff) on the subject of electronic instructions for use (IFU) for Near-Patient Testing devices. This survey will provide invaluable insights into the practice in the healthcare field in the EU. Why are MedTech…
Tehelj
April 24, 2024
January 24, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
Read More
November 24, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe RAC

This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
Read More
November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
Read More
November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

EPSCO meeting to be held on 30 Nov

Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is the meeting of the EU Ministers of Health. The upcoming EPSCO meeting agenda includes the implementation of IVDR and MDR with information from the French delegation, supported by the Belgian, German, Irish and Italian delegations. EPSCO is the meeting of the EU Ministers of Health. A public debate is proposed.…
Read More
November 10, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
Read More