Full text of EU MDR (Medical Device Regulation)
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EU MDR Table of Contents

Source EUR-Lex: https://eur-lex.europa.eu/
EU MDR Chapter 6

Chapter 6  –  Clinical evaluation and clinical investigations

Article 61– Clinical evaluation

Article 62– General requirements regarding clinical investigations conducted to demonstrate conformity of devices

Article 63– Informed consent

Article 64– Clinical investigations on incapacitated subjects

Article 65– Clinical investigations on minors

Article 66– Clinical investigations on pregnant or breastfeeding women

Article 67– Additional national measures

Article 68– Clinical investigations in emergency situations

Article 69– Damage compensation

Article 70– Application for clinical investigations

Article 71– Assessment by Member States

Article 72– Conduct of a clinical investigation

Article 73– Electronic system on clinical investigations

Article 74– Clinical investigations regarding devices bearing the CE marking

Article 75– Substantial modifications to clinical investigations

Article 76– Corrective measures to be taken by Member States and information exchange between Member States

Article 77– Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

Article 78– Coordinated assessment procedure for clinical investigations

Article 79– Review of coordinated assessment procedure

Article 80– Recording and reporting of adverse events that occur during clinical investigations

Article 81– Implementing acts

Article 82– Requirements regarding other clinical investigations

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