Clinical Investigations & Performance Studies

Legal Representative for Clinical Investigations

As your designated Legal Representative, we fulfil all regulatory obligations for clinical investigations of medical devices (MDR) and performance studies of IVDs (IVDR) in the EU, UK, and Switzerland.

  • Legal Representative for non-EU/UK/CH sponsors
  • Authority liaison
  • Document availability
  • Serious adverse event reporting coordination
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The Role of the Legal Representative

Under the EU Medical Device Regulation (MDR) Article 62(2) and the In Vitro Diagnostic Regulation (IVDR) Article 58(4), sponsors of clinical investigations or performance studies who are not established in the EU must designate a Legal Representative within the Union.

The Legal Representative acts as the sponsor's official point of contact for competent authorities. Similar requirements exist in the United Kingdom (UK MDR 2002) and Switzerland (MepV).

The Legal Representative is NOT the sponsor, investigator, or CRO. The Legal Representative's role is to ensure regulatory compliance and facilitate communication with authorities - not to conduct the study or make scientific decisions.

As your Legal Representative, MedNet EC-REP assumes the legal obligations defined in the applicable regulations, acting as your official representative in the respective jurisdiction.

What We Do as Your Legal Representative

All legal obligations under MDR/IVDR and national regulations

  • Authority Liaison: We act as the official point of contact for competent authorities and respond to their inquiries on your behalf.

  • Document Availability: We ensure that required documentation is available and accessible to authorities upon request.

  • Serious Adverse Event Coordination: We coordinate the reporting of serious adverse events and device deficiencies to competent authorities as required.

  • Regulatory Correspondence: We receive and forward all regulatory correspondence between authorities and the sponsor.

  • Address for Service: We provide a legal address within the jurisdiction for official communications and legal notices.

We serve as your official representative and point of contact for regulatory authorities. We ensure compliance with the formal requirements of being a Legal Representative - we do not conduct the study or make decisions on your behalf.

Sponsor Obligations

As the sponsor, you retain full responsibility for the clinical investigation or performance study. The Legal Representative supports you in meeting formal regulatory requirements but does not assume your obligations.

  • Complete study documentation including Clinical Investigation Plan (CIP), Investigator's Brochure, and informed consent forms

  • Qualified investigators and sites with appropriate training and resources

  • Safety monitoring and reporting in accordance with applicable regulations and timelines

  • Data management and quality assurance throughout the study

  • Insurance coverage as required by national regulations

  • Timely communication with the Legal Representative regarding any regulatory matters

EU, UK & Switzerland: Regional Requirements

Different jurisdictions have specific requirements for Legal Representatives. MedNet EC-REP provides coverage across all three major European markets.

European Union

MDR Article 62(2) and IVDR Article 58(4) require non-EU sponsors to designate an EU-based Legal Representative. MedNet EC-REP GmbH in Germany serves as your EU Legal Representative.

United Kingdom

UK MDR 2002 requires non-UK sponsors to designate a UK-based Legal Representative for clinical investigations. Our UK subsidiary serves as your UK Legal Representative.

Switzerland

The Swiss Medical Devices Ordinance (MepV) requires non-Swiss sponsors to designate a Swiss-based Agent. We provide coverage through MedNet Swiss GmbH.

For clinical investigations conducted across multiple jurisdictions, we can serve as your Legal Representative in all required countries, providing a single point of contact for streamlined regulatory communication.

How It Works

From engagement to study completion

  1. 1

    Initial Assessment

    We review your study scope, target countries, and timeline to confirm our role as Legal Representative.

  2. 2

    Formal Designation

    You formally designate MedNet EC-REP as your Legal Representative in the required jurisdictions.

  3. 3

    Authority Notification

    We are listed as the Legal Representative in all submissions to competent authorities.

  4. 4

    Ongoing Liaison

    Throughout the study, we handle regulatory correspondences and ensure document availability for authorities.

  5. 5

    Study Completion

    We support the formal closure of the study with authorities and maintain required documentation as per retention requirements.

Frequently Asked Questions

Common questions about Legal Representative services

Have more questions? Contact our team for clarification.

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