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Publication of MDCG 2022-9 rev.1 Summary of safety and performance template European Commission Updates Regulatory Affairs NewsletterEuropean 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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April 17, 2024
Recently updated standards Uncategorized

Recently updated standards

Multiple standards have been updated recently. Notably, these include: ISO 9001:2015/Amd 1:2024 Quality management systems — Requirements — Amendment 1: Climate action changes ISO 20658:2023 Requirements for the collection and transport of samples for medical laboratory examinations ISO 35001:2019/Amd 1:2024 Biorisk management for laboratories and other related organizations — Amendment 1: Climate action changes ISO 20688-2:2024 Biotechnology — Nucleic acid…
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April 17, 2024
MHRA weekly update (WC 08 Apr) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…
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April 17, 2024
Call for expertise on the development of IEC 61010-2-101 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Call for expertise on the development of IEC 61010-2-101

BSI are looking for experts in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
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April 17, 2024