Why a Legal Representation for Clinical Investigation Is Required
Legal background
Appointing a Legal Representative is not optional, it is a regulatory obligation under MDR for non-EU sponsors. The Legal Representative ensures that all communications with EU Competent Authorities are clear, complete, and compliant protecting both your study and your long-term market strategy.
A legal representative fulfils a number of important duties:
- Review of Clinical Investigation Documentation to be submitted to the Competent Authorities
- Submission of the request for authorisation of a clinical investigation to the Competent Authorities concerned
- Notification of Substantial modifications to, and early termination/temporary halt of a clinical investigation to the Competent Authorities concerned
- Communication of the end of the clinical investigation to the Competent Authorities concerned
- Submission of the Clinical Investigation Report to the Competent Authorities concerned
Our services
Your trusted Legal Representative for Clinical Investigations in the EU
As your appointed Legal Representative in the EU, we at Obelis ensure smooth and compliant execution of your clinical investigation. We review documentation, handle submissions to Competent Authorities, and manage the full lifecycle of your study, including substantial modifications, early terminations, and final report submissions. With our regulatory expertise, Obelis acts as your reliable EU contact point for the entire duration of your clinical investigation.
By partnering with us, you gain a centralised, knowledgeable, and responsive EU contact point that protects the integrity of your study and supports your broader market access goals.
Whether you are launching a first-in-human trial or expanding your post-market clinical follow-up, our legal representation helps you navigate the complexities of EU MDR clinical investigations with clarity and confidence.
FAQ
Frequently Asked Questions
A legal representative is mandatory for sponsors based outside of the European Union. This representative is responsible for ensuring compliance with EU Medical Devices Regulation (MDR 2017/745) during the clinical investigation process, serving as the official point of contact for EU Competent Authorities and managing key regulatory communications and documentation.
Any sponsor based outside the European Union who intends to conduct a clinical investigation involving a medical device within the EU is legally required to appoint a Legal Representative established in the EU. This requirement is outlined in Article 62.2 of the MDR and applies to all types of clinical investigations conducted in EU Member States.
No, the Legal Representative for clinical investigations is not the same as the EU Authorised Representative (EC REP). While both roles involve regulatory representation within the EU, the Legal Representative is specifically appointed for clinical investigations and is responsible for ensuring compliance throughout the study. The EC REP, on the other hand, represents the manufacturer for general market access and post-market activities related to CE-marked devices.
Yes, Obelis can act as your appointed Legal Representative for clinical investigations in the EU. With our headquarters in Brussels and deep expertise in EU regulatory requirements, we support non-EU sponsors by reviewing documentation, communicating with Competent Authorities, and ensuring full compliance with MDR. Partnering with Obelis gives you a reliable and knowledgeable EU contact point for the entire duration of your clinical study.
Yes. 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)
