Expert Legal Representation Support
Expert Legal Representation Support
Conducting a clinical investigation in the European Union demands full compliance with the EU Medical Device Regulation (EU MDR 2017/745), including the appointment of an EU‑based Legal Representative for non‑EU manufacturers. Qserve provides this essential service to ensure your clinical study progresses without administrative delays.
What is an EU Legal Representative?
Under Article 62(2) of the EU MDR, a non-EU manufacturer (the Sponsor) must appoint a Legal Representative established within the Union. This entity is not merely an administrative contact; they act as your legal persona in Europe. By appointing a representative, you ensure that a responsible party is physically and legally reachable by European authorities to answer for the conduct and compliance of your clinical investigation.
EU Legal Rep vs. the Authorized Representative (AR)
While your AR manages the general compliance and market presence of your devices, the Legal Representative is a specialized role focused strictly on the clinical trial phase. Their responsibilities include:
- Formal Accountability: Taking on legal responsibility for the sponsor’s obligations within the EU during the study.
- Regulatory Liaison: Serving as the primary point of contact for National Competent Authorities and Ethics Committees.
- Safety & Reporting: Ensuring that urgent safety issues and trial milestones are correctly communicated and recorded in the EUDAMED database.
Your Partner for EU MDR Compliance
As your EU Legal Representative, we act as your authorized point of contact with Competent Authorities, Ethics Committees, and other regulatory bodies throughout the European Union. Our team combines deep regulatory expertise with a practical approach in medical device clinical research, enabling us to support manufacturers across the entire lifecycle of a clinical investigation.
Why choose Qserve as your legal representative?
- Integrated services. Being the CRO executing your clinical investigation, and carrying responsibility for Legal Representation.
- Deep regulatory expertise built on decades of hands‑on experience in medical device and IVD regulations.
- Multidisciplinary teams of ex‑Notified Body specialists, clinicians, and regulatory professionals.
- Global understanding with a strong EU presence, ideal for non‑EU manufacturers entering the European market.
- Commitment to quality, compliance, and patient safety, ensuring your study aligns with the highest standards.
Our Services as your Legal Representative:
Regulatory Oversight & Accountability
We ensure that your clinical investigation meets all obligations under EU MDR, including correct submission pathways, documentation requirements, and ongoing reporting duties.
Communication With EU Authorities
We serve as your official liaison with EU Competent Authorities and Ethics Committees, facilitating approvals, responses to questions, and all required notifications.
Verification of Clinical Study Compliance
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.
Safety Reporting & Vigilance Coordination
We assist with serious adverse event (SAE) reporting, device deficiencies, and safety communications to ensure continuous compliance throughout the study.
Document Management & Archiving
We manage and securely store required regulatory documentation for the legally mandated retention period.
Support Across All EU/EEA Member States
Whether your study is conducted in one country or across multiple EU/EEA markets, we provide consistent guidance and centralized representation.
Supporting Successful Clinical Investigations
With Qserve as your EU Legal Representative, you can focus on generating high‑quality clinical evidence while we safeguard compliance and regulatory integrity. From study start-up to close-out, we offer the expertise and reliability needed to conduct clinical investigations confidently within the EU.
Supporting Successful Clinical Investigations
With Qserve as your EU Legal Representative, you can focus on generating high‑quality clinical evidence while we safeguard compliance and regulatory integrity. From study start-up to close-out, we offer the expertise and reliability needed to conduct clinical investigations confidently within the EU.
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FAQ
Still have questions? We are here to help.
Why do I need an EU Legal Representative?
Under the EU Medical Device Regulation (EU MDR 2017/745), any manufacturer located outside of the European Union must appoint an EU-based Legal Representative to conduct a clinical investigation within the EU/EEA. This representative acts as the official point of contact for regulatory bodies and ensures the study remains compliant with European law.
How is safety reporting handled?
Safety is a critical component of EU MDR. Qserve assists with the coordination of Serious Adverse Event (SAE) reporting and device deficiencies. We ensure that all vigilance communications are sent to the correct authorities promptly to maintain continuous compliance
How does Qserve support communication with authorities?
- Notified Bodies
- Ethics Committees
- Other relevant EU regulatory bodies
We facilitate the approval process, handle formal responses to queries, and manage all legally required notifications for all European authorities.
Which documents does Qserve verify for compliance?
Our experts ensure your study materials align with EU MDR and ISO 14155 standards. This includes:
- Clinical Investigation Plan (CIP)
- Investigator’s Brochure (IB)
- Safety measures and study protocols
- Mandatory regulatory documentation
Does Qserve provide representation in all EU countries?
Yes. Qserve provides centralized representation across all EU/EEA Member States. Whether your clinical investigation is localized to one country or spans multiple European markets, we offer consistent guidance and a single point of accountability.
What happens to my study documents after the investigation ends?
EU regulations mandate specific retention periods for clinical data. Qserve manages the secure storage and archiving of all required regulatory documentation to ensure you meet these long-term legal obligations.