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Clinical Trials Regulation for pharmaceutical studies (536/2014) applicable

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

News

IVDR D-Day!

MDCG issues guidance on clinical trials for medicinal products and in vitro diagnostic medical devices (IVDR)

MDCG issues guidance on the application of IVDR to legacy and other devices on the market prior to 26 May 2022 |

Today is Clinical Trials Day |

MDCG issues guidance on significant changes in design and intended purpose under IVDR |

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