Based on Article 61 of the MDR, implantable and class III devices are required to perform clinical investigations, except in some specific cases. This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.
Please note that devices which are neither class III nor implantable are outside the scope of this guidance. You may refer to MDCG 2020-5 and MDCG 2020-6 to study the need for a clinical investigation for such devices.
If you would like to confirm whether an implantable or a class III device can be exempted from performing clinical investigations, please consult the guidance. A table with a detailed description is provided and flowcharts demonstrating the criteria can also be found in the guidance.