Glossary · EU medical devices: MDR
Clinical investigation (MDR)
Also known as: MDR clinical investigation, Medical device clinical study
Under the EU Medical Device Regulation (EU) 2017/745, a clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. Articles 62 to 82 and Annex XV set the requirements for its application, conduct, sponsor duties, safety reporting and results.
- EU
- MDR
In one sentence
A clinical investigation under MDR Articles 62–82 is a study in human subjects to assess a device’s safety or performance, run by a sponsor under Annex XV.
Example
A start-up sponsors a multicenter investigation of a new class III heart valve: it submits the clinical investigation plan and investigator’s brochure to the member states concerned, obtains ethics committee approval and follows ISO 14155.
How it applies
- Sponsor: The sponsor, often the manufacturer, applies to the member states where the investigation takes place and may not start until the conditions of the MDR and national law, including the ethics committee opinion, are met. A sponsor outside the EU needs a legal representative in the EU.
- Documents: Annex XV requires, among others, a clinical investigation plan, an investigator’s brochure and informed consent documents. ISO 14155 is the good clinical practice standard for designing and running the study.
- Safety reporting: Serious adverse events and device deficiencies that could have led to one are recorded and reported to the member states concerned.
- Results: The sponsor writes a clinical investigation report and a summary intended for the public. Registration and results publication run through EUDAMED; check which modules are mandatory.
- Post-market studies: Investigations of CE-marked devices within their intended purpose, for example as part of PMCF, follow a lighter notification route.
- Technical documentation: The clinical investigation report becomes input to the clinical evaluation and is referenced in the technical documentation.
MDR clinical investigation vs. clinical trial
A clinical investigation assesses a device under the MDR. A clinical trial assesses a medicinal product under the Clinical Trials Regulation (EU) No 536/2014 and follows ICH E6(R3). The ethical principles are shared, but the application routes, databases and standards differ. For IVDs the counterpart is the performance study.