To sell in the European Union, manufacturers of medical devices – whether from the EU or not – must demonstrate safety and performance of their products through clinical data. Clinical data must be representative of the population targeted for that device, meaning that if the target patients are European adults, data collected in a world region with significantly different demographic data are not adequate.
Non-EU manufacturers can carry out a clinical investigation to collect data on their devices in an EU country, even if your device is not yet CE-marked. Any individual, company, institution, or organisation which takes responsibility for the clinical investigation’s initiation, management, and financing setting up is the clinical investigation’s sponsor, as defined in the Medical Devices Regulation.
Clinical investigations plan
Sponsors have to carry out their clinical investigation according to a clinical investigation plan (CIP). A CIP defines the investigation’s rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis. Also, the plan should include sufficient details for competent authorities and ethics committees to assess if any potential risks to humans are, after their minimisation, justified considering the expected device’s clinical benefits.
MDCG 2024-3, the guidance document on clinical investigations from the Medical Device Coordination Group, provides guidelines for sponsors to facilitate the understanding of regulatory requirements.
CE marking and intended purpose
Clinical investigations can involve medical devices for different purposes:
- Devices which are not CE-marked to collect clinical data to demonstrate conformity with MDR GSPRs – e.g., clinical trials for high-risk devices
- CE-marked devices used outside of their intended use to assess an extended device’s use
- CE-marked devices used within their intended use or population with the scope to collect more data, e.g. post market clinical follow up studies (PMCF studies)
From Article 62 to Article 80, MDR sets the requirements to conduct a clinical investigation. Additionally, sponsors must take into account national requirements of the Member State where the investigation takes place and most importantly, the authorisation to receive prior to the clinical investigation start.
Legal representative for clinical investigations
According to MDR art.62.2, non-EU sponsors of a clinical investigation must appoint a legal representative based in the EU. The legal representative is responsible for ensuring compliance with the sponsor’s obligations established in the MDR and is considered as the addressee of all communication from the Competent.
As part of our legal representative services, Obelis assists sponsors of clinical investigations with:
- Review of Clinical Investigation Documentation to be submitted to the Competent Authorities
- Authorisation request submission to the competent authorities concerned
- Substantial modifications’ notification as well as early termination or temporary halt of a clinical investigation to the competent authorities concerned
- Communication of the clinical investigation’s end to the competent authorities concerned
- Clinical Investigation Report’s submission to the Competent Authorities concerned
Do you have any questions on how to conduct a clinical investigation in the EU?
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Simona Varrella
Regulatory Intelligence & Innovation
19.06.2024
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