What is the difference between a regulatory submission for a drug and one for a medical device?

1 company with a published answer

  1. MultiHealth group

    “Drugs are governed by the CTIS and the European Clinical Trials Regulation, while medical devices must comply with the requirements of the MDR and the IVDR, along with specific national procedures involving the competent authorities and ethics committees.”

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Surface ID
urn:readyscan:corpus:buyer-question:multihealth-group-q115036354-answer-afa169fff0c16f1f02a7
Material fingerprint
fnv1a64:dc7a7eaa4f6bee58
Membership fingerprint
fnv1a64:13eda3f164d7874f
Published
2026-10-29
Modified
2026-10-29
ready-scan-subjects/Q115036354
revision Q115036354:content:bf641adcdb087deb

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