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.…
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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…
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Sertio Oy from Finland is designated as a notified body under the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVDR). To date, there are twelve notified bodies designated under the EU IVDR. This designation was published on NANDO database on 31 October September 2023. This can be considered as significant news to the European diagnostics industry.
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Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…
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The European Commission DG Sante has launched a “MDR and IVDR Communication Survey”. The objective of this online survey is to better understand the information needs around the EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). It focuses on how the stakeholders are affected by the regulations. Members are encouraged to participate in this survey.…
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