The Medical Devices Introductory Course 2020

Clinical Investigations: Class III and implantable devices (1)

Article 61 (4), Clinical investigations should always be performed for these devices with certain exceptions: • device designed by modifications of a device already marketed by the same manufacturer AND equivalence demonstrated AND endorsed by the NB AND the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant GSPRs • Article 61 (5), specifies additional criteria for when equivalency is claimed to a device where the manufacturer is different (e.g. a contract should be in place) PMCF plan still needed and NB should check post-market studies are appropriate

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Clinical Investigations: Class III and implantable devices (2)

Article 61 (6) also lists exceptions for devices placed on the market under MDD and for the following products: • sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors Compliance with Common Specifications (CS) required, if available

Note: Clinical Investigations may be appropriate for any class of device if it is necessary to generate new or additional clinical data necessary to establish conformity with relevant GSPRs. Should be identified as part of the clinical evaluation

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