Skip to main content
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes a proposal amending the EU MDR and EU IVDR

A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs). This proposal includes:…
Tehelj
January 24, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

European Commission study on availability of medical devices on the EU market

European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has contracted Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) to launch a study for manufacturers of medical devices and in-vitro diagnostics and authorized representatives. The aim of the study is to collect information on the transition of devices to medical devices and in-vitro diagnostic medical devices regulations.…
Tehelj
December 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
Tehelj
December 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech 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…
Tehelj
November 17, 2023