Medical Device News – December 2022 Regulatory Update

Medical Device made Easy Podcast · Dec 6, 2022

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Europe

Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346

Reclassification of groups of certain active products without an intended medical purpose

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347

Updated information pack for candidate EU reference laboratories published…