The Medical Devices Introductory Course 2020

When are they needed? CLINICAL INVESTIGATIONS

The Organisation for Professionals in Regulatory Affairs

Clinical Investigations: MDR Article 62

Part of the Clinical Evaluation process and conducted for the following purposes:

Performance

Clinical benefits

Safety/ side effects

Article 2 Point (1) gives a definition of those specific medical purposes that define a product as a medical device

The Organisation for Professionals in Regulatory Affairs