Module 15 Presentations

10/04/2024

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

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Article 82

Requirements regarding other clinical investigations –bearing CE-mark, no additional interventions (observational) If a Clinical Investigation is not performed according to any of the purposes listed in Article 62 (1) it shall comply with other aspects of Article 62 ( 62 (2 & 3), 62 (4) points b, c, d, f, h & i. Article 62 (4) & 62 (6) ) If the Clinical Investigation is not performed according to any of the purposes listed in Article 62(1) each member state shall define any additional requirements to protect the rights, safety, dignity and well-being of subjects in their state.

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