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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Public consultation: conflict-of-interest rules under the EU Health Technology Assessment Regulation

The European Commission have launched an online public consultation on the draft implementing act on the management of conflicts of interest in Health Technology Assessments. The draft implementing act provides rules for managing conflicts of interest of actors such as the representatives in the Member State Coordination Group and its subgroups, assessors, patients, and clinical and other experts who participate…
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June 4, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech 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.…
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November 17, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Formal stakeholder body created under the Health Technology Assessment Regulation

The Health Technology Assessment Stakeholder Network had its first meeting in Brussels on June 14th, where a formal stakeholder body under the Health Technology Assessment Regulation was created. There were representatives from stakeholder organisations and Member States in the Health Technology Assessment Coordination Group. This meeting was an opportunity to discuss the role of stakeholders in the implementation of the…
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June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EU Harmonisation of standards update

The European Commission's Directorate-General presented at the Medical Device Coordination Group (MDCG) – Subgroup meeting on Standards, held on 12 June 2023. The presentation and the meeting minutes will be published in the Register of Commission Expert Groups and Other Similar Entities, once approved by the members.
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June 16, 2023