Module 15 2022

20/05/2022

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.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

11

Article 74

Clinical investigations regarding devices bearing the CE marking Clinical investigation conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’), Clinical Investigation on a CE marked product involving submitting subjects to procedures additional to those performed under the normal conditions of use of the device The additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 73. e.g: Ionising radiation, prolonged surgery

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

12

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