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MDCG issues guidance on substantial modification of clinical investigation under MDR |
https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf
News
20 May
MDCG issues guidance on the application of IVDR to legacy and other devices on the market prior to 26 May 2022 |
20 May
Today is Clinical Trials Day |
04 May
MDCG issues guidance on significant changes in design and intended purpose under IVDR |
01 Apr
Directorate for Health and Food Safety issues joint implementation plan for the IVDR |
24 Mar
MDCG issues updated guidance concerning Safety and Performance summary
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