Module 15 2022

20/05/2022

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.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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Annex XV Clinical Investigations

Annex XV CLINICAL INVESTIGATIONS ● Chapter I. General Requirements ● Chapter II. Documentation Regarding The Application For Clinical Investigation ● Chapter III. Other Obligations Of The Sponsor

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

14

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