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EU Commission issues guidance on the clinical investigation report |
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52023XC0508%2801%29
News
23 Aug
EU Commission issues decision flowchart for devices covered by the MDR transitional period |
16 Aug
EU Commission issues guidance on the summary of the clinical study report |
15 Aug
CEO presentation on Adverse Events handling under the MDR (2017/745) |
10 Jul
EU Commission adopts decision for safe EU-US data flows |
12 May
MDCG updates guidance on significant changes for MDD and AIMDD devices |
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