Mandatory EU-based representation for non-EU sponsors running a medical device clinical investigation under MDR Article 62(2), so your study stays compliant from submission to close-out.
Under Article 62(2) of the EU MDR , a sponsor not established in the Union must appoint a person established in the EU as its legal representative before running a clinical investigation. The representative takes on the sponsor's regulatory obligations for the duration of the study and is the official addressee for all communications, legally, contacting them is the same as contacting the sponsor directly.
The two roles are often confused, and only one applies before your device is CE-marked. An EU Authorized Representative acts under Article 11 once a device is placed on the market. An EU Legal Representative acts under Article 62(2), for a pre-market clinical investigation. If your device isn't CE-marked yet and you're running a study, you need a legal representative, not an authorized representative.
If your device is already CE-marked and you need ongoing market representation instead, see our EU Authorized Representative (EC REP) page.
We ensure that your clinical investigation meets all obligations under EU MDR, including correct submission pathways, documentation requirements, and ongoing reporting duties.
We serve as your official liaison with EU Competent Authorities and Ethics Committees, facilitating approvals, responses to questions, and all required notifications.
Our experts verify that your clinical investigation plan (CIP), Investigator’s Brochure, safety measures, and study documentation comply with EU MDR and ISO 14155 requirements.
We assist with serious adverse event (SAE) reporting, device deficiencies, and safety communications to ensure continuous compliance throughout the study.
We manage and securely store required regulatory documentation for the legally mandated retention period.
Whether your study is conducted in one country or across multiple EU/EEA markets, we provide consistent guidance and centralized representation.
A missed notification or an incomplete safety report can stall a study or trigger regulatory scrutiny. As your legal representative, we monitor submission pathways, safety reporting, and documentation throughout your clinical trial so you can focus on generating clinical evidence while we safeguard compliance from start-up to close-out. Where the study also needs a broader EUDAMED submission, we coordinate that in parallel rather than as a separate handoff.
Frequently Asked Questions
Can Qserve act as both our CRO and our EU Legal Representative for the same study without a conflict of interest?
Yes. MDR Article 62(2) does not prohibit a single organisation from serving as both CRO and EU Legal Representative for the same clinical investigation.
Does this service cover clinical investigations in the UK or Switzerland?
Article 62(2) is an EU MDR requirement, so it applies to investigations run under EU MDR. The UK and Switzerland regulate devices under their own separate frameworks and don't require an "EU Legal Representative" under this article, though sponsors running studies there may need equivalent in-country representation.
How long does it take to appoint an EU Legal Representative, and will it delay the start of our study?
Appointing an EU Legal Representative is a contractual step, not an application or approval process. Unlike notified body engagement, there's no external queue to wait on.
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