For implantable and Class III devices, the requirement to conduct a clinical investigation as part of the CE marking process has not changed compared to the EU Medical Device Directive (MDD). However, whereas the MDD included minimal requirements regarding such clinical investigation, the EU Medical Device Regulation (MDR) provides detailed legal requirements for conducting a clinical evaluation and clinical investigation in alignment with EN ISO 14155, Clinical investigation of medical devices for human subjects. Thus, within the EU, clinical investigations must be conducted within the constructs of Annex XV of the EU MDR and recognized ethical principles.
Under MDR, manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI. This evaluation must provide sufficient clinical evidence to demonstrate:
- Confirmation of conformity with relevant general safety and performance requirements (GSPRs) under normal conditions of the intended use of the device.
- Evaluation of the undesirable side effects and the acceptability of the benefits and risks of use.
In this guide, we provide a checklist for designing a successful clinical investigation plan and review key considerations for operationalizing medical device clinical investigations.