Essentials of European Medical Device Regulatory Affairs

MDR Article 61 Clinical evaluation

• Clinical investigations need NOT be performed in the following cases – sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specification , where such a common specification is available • Existing devices will NOT be automatically grandfathered into the new Regulation without need for clinical investigation or further documentation.

The Organisationfor Professionals inRegulatory Affairs

Type of Clinical Evaluation

• Clinical literature review

• data from equivalent device • data from their own device • clinical investigation planning in accordance with EN ISO 14155 Clause 5.3 • Clinical investigation(s) • Combination of the two

For implantable/Class III the default expectation is that there will be a clinical investigation

The Organisationfor Professionals inRegulatory Affairs