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Clinical Investigations of Medical Devices: An Overview of Regulatory Requirements
The MDR defines a clinical investigation in Art. 2 (45) as “a systematic investigation involving one or more human subjects and conducted for the purpose of evaluating the safety or performance of a device”. The regulatory framework for clinical trials with medical devices in Europe is summarized below.
When are clinical trials required?
Clinical trials must generally be conducted by the manufacturer if one or more of the following conditions are met:
- there are gaps in the clinical data that cannot be filled by other sources,
- it is a class III medical device or implant (exception: modification of an existing medical device and the manufacturer fulfills the associated further requirements (Art. 61 (4) MDR)),
- a completely new medical device with new features and functions is to be placed on the market,
- changes to an existing medical device have an impact on clinical safety and performance and/or
- the medical purpose of an existing medical device is extended.
Clinical trials in the MDR
The European Medical Devices Regulation (EU) 2017/745 (MDR) contains requirements for clinical trials in Articles 62 to 82 and Annex XV, which include the following aspects:
- General obligation
- Patient safety
- Emergency situations
- Indemnification
- EUDAMED-related provisions
- Types of clinical trials
- Information flows
- Measures taken by member states
- Evaluation of clinical trials
- Adverse events
Guidance documents and standards
The Medical Device Coordination Group (MDCG) of the EU Commission has published a series of guidance documents for clinical trials with medical devices:
Do you have any questions?
This article is intended solely for general informational purposes and does not constitute legal advice. All content was reviewed by experts prior to publication and is regularly checked for currency, completeness, and accuracy. Despite careful preparation and quality control, errors, omissions, or changes in the legal situation that have occurred in the meantime cannot be ruled out.
