Authorized and Legal Representative: key roles for compliance
In the global regulatory environment for medical and in vitro diagnostic devices, manufacturers operating outside a given market are often required to appoint a local representative. Two distinct roles exist in this context: the Authorized Representative and the Legal Representative.
Although both serve as intermediaries for manufacturers without a legal presence in a specific region, their responsibilities differ substantially. Understanding these roles is essential for ensuring compliance and avoiding regulatory delays.
What is an Authorized Representative?
An Authorized Representative is a regulatory figure appointed by a manufacturer who does not have a registered office in the country where it intends to market a medical or IVD device. This representative acts as the interface between the manufacturer and the national competent authorities.
When is it required?
This role becomes mandatory when a manufacturer places a device on the market without having a local legal entity in that country.
What are the responsibilities?
The Authorized Representative plays a key role in ensuring regulatory oversight. Their tasks include:
- Maintaining up-to-date technical and regulatory documentation
- Communicating with competent authorities
- Managing incident reports and customer complaints
- Supporting inspections and audits
- Overseeing post-market surveillance activities
In some countries, this representative is also the official holder of the product registration, which increases both the responsibility and strategic importance of the role. Choosing a competent and experienced partner is therefore critical for ensuring uninterrupted market access and regulatory compliance.
What is a Legal Representative?
A Legal Representative is a regulatory figure required in several countries when a manufacturer conducts a clinical investigation in a territory where it does not have a legal presence.
This representative acts as the local legal contact for the competent authorities and assumes responsibility for ensuring that the study complies with the applicable national laws and regulations.
When is it required?
A Legal Representative is required when a clinical investigation is initiated in a country that mandates local legal representation for foreign manufacturers. This applies regardless of the risk class of the device or the stage of the study, and requirements may vary depending on local legislation.
What does the role involve?
While specific responsibilities may differ across jurisdictions, the Legal Representative is generally responsible for:
- Acting as the formal legal contact for regulatory authorities
- Ensuring that the clinical investigation is conducted in full compliance with local requirements
- Supporting the manufacturer during audits and inspections
- Responding to any regulatory issues or non-compliance throughout the study
This role is not involved in the commercialisation of the device. Instead, it exists to ensure legal accountability and facilitate cooperation with competent authorities during the investigation.
Strategic considerations when appointing a representative
Selecting the appropriate representative (whether for market access or clinical investigations) is a decision that carries significant regulatory and operational implications. The role goes far beyond formal compliance: it involves ongoing communication with authorities, accurate documentation management, and direct accountability in the event of non-conformities or inspections.
A superficial or inadequate choice may compromise both timelines and access to the target market.
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