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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…
Tehelj
June 4, 2024
April 17, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

Publication of MDCG 2022-9 rev.1 Summary of safety and performance template

Directorate-General for Health and Food Safety has published the first revision of MDCG 2022 – 9: “MDCG 2022-9 rev.1 – Summary of safety and performance template”.  Members are requested to provide any comments to Regulatory@bivda.org.uk by 30 April.
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March 21, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes two implementing decisions on medical device harmonised standards

The European Commission have published two Implementing Decisions regarding medical device harmonised standards: "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products."This Implementing Decision…
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