From Liaison to Oversight: Defining the Legal Representative’s Function Under IVDR

By: Maria Salman: Senior Specialist- Regulatory Affairs at ARC Regulatory

What is a Legal Representative (LR)?

Per Article 58(4) of the In Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) “Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its LR. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor”.

The requirement for non-European Union (EU) established Sponsors to appoint a LR within the EU is intended to ensure that a legal entity exists within the EU jurisdiction that can be held accountable for performance study. While the LR is tasked with ensuring the sponsor meets all relevant regulatory obligations, the IVDR itself doesn’t specify exactly how these duties should be carried out.

In lieu of an IVDR-specific guidance, we can refer to the Medical Device Coordination Group Document (MDCG 2021-6) ‘Regulation (EU) 2017/745 -Questions & Answers regarding clinical investigation’ as the wording in the MDR regarding the obligation for non-EU-based Sponsors to appoint LR mirrors that of the IVDR.

When is a LR required?

The requirement to appoint a LR applies only to sponsors not established within the EU, meaning those without a registered place of business in an EU Member State. Sponsors already established in the EU are expected to fulfil their legal and regulatory obligations directly.

In the absence of an explicit provision within the IVDR, it remains uncertain how National Competent Authorities (NCAs) would view an attempt by an EU-based Sponsor to appoint a LR. However, it appears unlikely that NCAs would permit an EU Sponsor to effectively transfer their legal obligations to a third party simply by designating a LR.

Establishing a LR in the EU Under IVDR: Key Steps and Considerations

Under the In Vitro Diagnostic Regulation (IVDR), appointing a LR is a critical step for any Sponsor conducting a performance study in the EU, if the Sponsor is not established in the EU. The LR serves as the Sponsor’s official liaison with EU regulatory authorities and carries shared accountability for ensuring regulatory compliance.

To formalize this relationship and clearly define responsibilities, sponsors must establish a study-specific Power of Attorney (PoA) or contract with the LR. This agreement should go beyond basic administrative details and reflect a clear understanding of obligations, communication, and oversight. Key elements to include are:

Comprehensive Information Sharing

• The sponsor must commit to providing the LR with all relevant study information. This ensures the LR can fulfil its oversight duties and verify compliance with IVDR requirements, including those delegated to third parties.

Immediate Notification of Non-Compliance

• The LR must promptly notify the sponsor of any instances of non-compliance or potential breaches identified during oversight activities. This ensures timely corrective action and reinforces the LR’s role as an active compliance partner.

Clear Role Delineation When the LR Is Also a Contract Research Organisation (CRO)

• If the LR is also a CRO, the contract must clearly distinguish which tasks are being performed in the capacity of Legal Representative and which fall under CRO responsibilities. This distinction avoids overlap, confusion, or gaps in accountability.

Defined Verification Activities

• The agreement should specify how the LR will conduct verification activities, such as audits, document reviews, or other oversight measures. Establishing these procedures upfront helps ensure consistency, transparency, and regulatory readiness throughout the study lifecycle.

Roles and Responsibilities of Legal Representative Under the IVDR

It’s commonly understood that the LR simply acts as the primary point of contact for communication with EU authorities, serving as the official liaison between the sponsor and regulatory bodies. However, the LR’s role goes beyond this, and they are also responsible for ensuring the sponsor meets their obligations under the IVDR (and by extension, EN ISO 20916:2024), including oversight of any activities delegated to third parties.

1. Beyond Liaison: The LR's Oversight Obligations 

• According to the MDCG Guidance, the LR’s responsibilities cannot be delegated back to the Sponsor or a CRO. This distinction is crucial, as it underscores the LR’s independent accountability within regulatory framework. To fulfil their oversight duties, the LR may verify compliance through various mechanisms, such as:
• Conducting audits of the sponsor and their subcontractors.
• By implementing other agreed-upon oversight measures between the relevant parties.

2. Access and Availability: A Key Requirement 

The LR should have permanent and integral availability and access to all technical documentation and study documentation. This includes, but is not limited to:

• Trial Master File (TMF) and Investigator Site File (ISF)
• Contracts & financial arrangements
• Evidence of site suitability & study team qualification
• Study records such as communications, monitoring reports, Serious Adverse Event (SAE reports) (i.e. specific records, not general procedures).

3. Shared Verification, Distinct Responsibilities

• The LR’s role includes verifying, alongside the Sponsor, that all required documents and records are complete.
• However, this responsibility does not replace the Sponsor’s own obligations, nor does it mean evaluating/review of data of each document.
• Accordingly, if there is a breach of any of the sponsor’s obligations under the IVDR, this provision would naturally be interpreted to mean that liability for such a breach may extend to the legal representative, in addition to the Sponsor.

4. Data Retention and Continuity

• Finally, the LR must retain access to, or a copy of, all study data in the event that the Sponsor goes bankrupt or ceases operations.
• To safeguard against such scenarios, it is strongly recommended that the LR maintains a securely stored copy of all relevant documentation within the European Economic Area (EEA). This ensures both regulatory continuity and data integrity, even if the sponsor’s business continuity is disrupted.
• As stated previously, this documentation may need to include all relevant technical documentation for the device for performance study, along with study specific records from the Trial Master File.

Checklist for Sponsors Appointing a LR Under IVDR

Before appointing an LR for your EU study, ensure the following essentials are in place:

1. Appointment & Contract

☐ Issue a study-specific PoA or contract defining LR authority and scope.

☐ If LR also acts as CRO, clearly separate LR and CRO tasks.

☐ Include indemnity, liability, and termination terms.

2. Access & Oversight

☐ Provide LR with all relevant study information and unrestricted access to all technical documentation and study documentation (e.g. TMF, ISF, contracts, SAE reports).

☐ Agree on how compliance will be verified.

☐ Require LR to immediately report non-compliance.

3. Data Retention

☐ Ensure LR can retain or access all study data if the sponsor ceases operations.

☐ LR should securely store key documentation within the EEA.

4. Ongoing Compliance

☐ Treat the LR as a compliance partner, not just a liaison.

☐ Maintain open communication and review the arrangement regularly.

In summary: A clear, well-structured LR agreement supports compliance, protects both parties, and strengthens oversight of a performance study under IVDR.