Essentials of European Medical Device Regulatory Affairs

Clinical Investigation Vs Clinical Evaluation

Clinical Investigation • Class of device • Class III and IIb Implantable devices clinical investigations shall be performed Completely new / novel device New indication for a established device New materials / new location / longer use Unable to demonstrate transferability of results obtained in the clinical evaluation • • • •

Clinical Evaluation • Class of device • To be conducted for all devices •

History of use, publication of clinical performance and safety

• Can demonstrate transferability of results documented in scientific literature • Equivalent devices

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Clinical Evaluation

The contents of a clinical evaluation report (CER) are described in a MEDDEV.

The clinical evaluation report will contain • Scientific literature of equivalent devices • Results of clinical investigations • Device should be discussed in the context of alternative treatments. For Class III and Class IIb implanted devices the company can ask the clinical expert panel for advice on the development strategy and about the planned clinical investigation.

The panel’s advice needs to be recorded in the CER.

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