Module 15 Presentations

10/04/2024

Clinical Investigations MDR – Chapter VI

Clinical investigations Articles 62 to 82 ● Article 62: General requirements regarding clinical investigations conducted to demonstrate conformity of devices ● Article 74 (1): Clinical investigations regarding devices bearing the CE marking - within the scope of its intended purpose, additional procedures are invasive or burdensome ● Article 74 (2): Clinical investigations regarding devices bearing the CE marking - outside the scope of its intended purpose ● Article 82: Requirements regarding other clinical investigations – bearing CE-mark, no additional interventions (observational)

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Article 62

General requirements regarding clinical investigations conducted to demonstrate conformity of devices Clinical Investigations will be designed, authorised, conducted, recorded and reported in accordance with the relevant articles (62-80) If the Sponsor is not established in the EU, a legal representative is appointed. Clinical Investigations shall be designed and conducted in a way that protects the rights, safety, dignity and well-being of the subjects taking part. Allow for any subject, or a subjects legal designated representative, to withdraw their consent without prejudice, without providing a reason. Ensure the Investigator, and all personnel, is relevantly qualified to perform their tasks Ensure the facilities where the Clinical Investigation is being conducted, are, and remain suitable to conduct the Clinical Investigation.

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