MDR Article 62(2) generally requires the sponsor of a clinical investigation who is not established in the European Union to ensure that a natural or legal person established in the EU acts as its legal representative.
The legal representative is responsible for ensuring compliance with the sponsor’s obligations under the MDR and receives the regulatory communications addressed to the sponsor. Communications with the legal representative are considered communications with the sponsor.
The same paragraph allows Member States to apply limited exceptions and accept an EU-based contact person in certain circumstances. Sponsors should therefore confirm the requirements of every Member State involved before submitting the clinical investigation application.
Read the consolidated EU Medical Device Regulation
When Is an EU Legal Representative Required?
The requirement should be assessed when:
- the clinical investigation sponsor is not established in the European Union;
- the proposed investigation falls within the MDR clinical investigation framework;
- the investigation will be conducted in one or more EU Member States;
- the relevant Member State has not applied an exception permitting the appointment of a contact person instead.
Article 62 covers clinical investigations intended to establish or verify aspects such as device performance, clinical benefit, safety and undesirable side effects for conformity assessment purposes.
Post-market clinical follow-up investigations under Article 74 and other clinical investigations under Article 82 may follow different regulatory routes. Sponsors should determine the applicable route before deciding which representation arrangements are required.
What Is the Legal Representative Responsible For?
Article 62(2) assigns two central functions to the legal representative.
Ensuring Compliance With Sponsor Obligations
The legal representative is responsible for ensuring that the sponsor complies with the obligations applicable under the MDR.
The appointment does not change the identity of the sponsor or remove the sponsor’s responsibilities. The sponsor and legal representative need documented procedures that define oversight, communication, escalation and regulatory decision-making.
Receiving Regulatory Communications
The legal representative is the EU addressee for communications with the sponsor under the MDR.
A communication sent to the legal representative is treated as a communication with the sponsor. The representative must therefore be able to receive, assess and escalate requests from competent authorities within the required timelines.
Legal Representative Versus EU Authorised Representative
A legal representative for a clinical investigation is not the same as an EU Authorised Representative appointed for market access.
| Role | Legal basis | Appointed by | Primary purpose |
|---|---|---|---|
| Clinical investigation legal representative | MDR Article 62(2) | A non-EU clinical investigation sponsor | Representation connected with the sponsor’s clinical investigation obligations |
| EU Authorised Representative | MDR Article 11 | A non-EU medical device manufacturer | Representation connected with placing a device on the EU market and the manufacturer’s regulatory obligations |
A company may need a clinical investigation legal representative before or during a pre-market investigation and an EU Authorised Representative when placing the finished device on the EU market.
The appointments, mandates and responsibilities must be assessed separately, even when the same organisation is capable of providing both services.
Can a Contact Person Replace the Legal Representative?
Article 62(2) allows Member States to choose not to require a legal representative for certain investigations.
For an investigation conducted only in one Member State, or in that Member State and a third country, the Member State may permit the sponsor to appoint a contact person established in its territory instead. For an investigation conducted in more than one Member State, the participating Member States may also permit an EU-based contact person, provided that they agree to apply the exception.
The exception is not automatic, a sponsor should not assume that appointing a contact person will be accepted without confirming the position of every participating Member State.
How to Appoint an EU Legal Representative
1. Confirm the Regulatory Route
Determine whether the study falls under Article 62, Article 74, Article 82 or another applicable route.
Record the basis for that determination and confirm the application requirements in each participating Member State.
2. Confirm Whether an Exception Applies
Ask each relevant competent authority whether it applies the Article 62(2) contact-person exception to the proposed investigation.
Do not rely on the position of one Member State when the investigation will be conducted in several countries.
3. Select an EU-Established Representative
The representative must be a natural or legal person established in the European Union.
The organisation should have the regulatory capability, availability and operational procedures required to oversee communications and the sponsor’s applicable MDR obligations.
4. Define the Appointment in Writing
The agreement should clearly identify:
- the sponsor and legal representative;
- the clinical investigation covered;
- the countries included;
- the scope of each party’s responsibilities;
- communication and escalation procedures;
- safety-reporting interfaces;
- document-access requirements;
- change-control and termination procedures.
5. Establish Operational Communication
Define named contacts, backup contacts and response procedures before submitting the clinical investigation application.
Competent-authority requests, safety information and regulatory deadlines must be transmitted to the appropriate sponsor personnel without avoidable delay.
6. Maintain the Arrangement Through Study Closure
The representative should remain available for the applicable regulatory communications and obligations throughout the investigation and its formal closure.
Any change of representative, sponsor details or communication contacts should be assessed for notification requirements in the participating Member States.
Information Needed Before Appointment
A prospective legal representative will normally need sufficient information to understand the investigation and the obligations it is being asked to oversee.
Sponsors should be prepared to provide:
- the sponsor’s legal name, address and corporate details;
- the clinical investigation protocol or current synopsis;
- the investigational device description and regulatory status;
- the intended purpose and development stage;
- the proposed Member States, sites and submission route;
- the expected application and study timelines;
- sponsor, CRO and safety-reporting contacts;
- applicable quality and regulatory procedures;
- the proposed division of responsibilities;
- information about existing EU Authorised Representative appointments, where relevant.
The final information requirements should be defined according to the investigation, participating countries and scope of the legal representative’s mandate.
How Does ISO 14155 Relate to the Appointment?
ISO 14155 provides good clinical practice principles for the design, conduct, recording and reporting of medical device clinical investigations.
It does not create the legal representative requirement. That requirement comes from MDR Article 62(2).
Sponsors should therefore treat the MDR appointment and ISO 14155 compliance as related but separate elements of clinical investigation governance. The legal representative agreement should be consistent with the sponsor’s clinical investigation procedures, quality system and allocation of responsibilities.
Questions to Ask a Potential Legal Representative
Before making an appointment, ask:
- Which MDR clinical investigation obligations are included in the proposed mandate?
- How will competent-authority communications be received, assessed and escalated?
- What sponsor documentation must be reviewed before the appointment is accepted?
- How are safety reports, urgent requests and regulatory deadlines managed?
- Which Member States and submission pathways does the organisation support?
- How are sponsor, CRO and legal representative responsibilities documented?
- What happens if the investigation, participating countries or sponsor details change?
- How will the appointment be maintained through study closure?
Frequently Asked Questions
A legal representative is generally required when a sponsor not established in the EU conducts a clinical investigation falling under Article 62. However, Member States may permit an EU-based contact person in the circumstances described in Article 62(2). Other investigation routes must be assessed separately.
No. The clinical investigation legal representative is appointed under Article 62(2) in connection with a non-EU sponsor’s clinical investigation. An EU Authorised Representative is appointed under Article 11 by a non-EU manufacturer in connection with placing devices on the EU market.
No. The sponsor remains the sponsor. The legal representative has the responsibilities assigned by Article 62(2), including ensuring compliance with the sponsor’s MDR obligations and receiving regulatory communications.
The MDR requires the representative to be established in the European Union. It does not generally require a separate representative in every Member State. National application procedures and any contact-person arrangements must still be confirmed for each participating country.
Where a legal representative is required, the appointment should be completed before the clinical investigation application is submitted so that the representative and communication arrangements can be identified correctly in the application.
IVD performance studies are governed by the IVDR rather than MDR Article 62. See our guide to the IVDR legal representative for clinical performance studies.
Need an EU Legal Representative for an MDR Clinical Investigation?
MDx CRO provides legal representative services for non-EU sponsors conducting medical device clinical investigations in the European Union.
Our team can support the appointment, define the communication and oversight procedures, coordinate regulatory interactions and connect the representation role with the wider clinical investigation programme.
