As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer data and the completion of EUDAMED registrations. This formal role is essential for ensuring compliance with EU regulations governing medical devices (MDR (EU) 2017/745), in vitro diagnostic devices MDR (EU) 2017/746 (IVD), and the AI Act 2024/1689.
Device Registration in EUDAMED
EUDAMED is the European Union’s central database for medical devices and organizations involved in their distribution within the EU market. Registration is mandatory under EU Regulation MDR 2017/745 (Articles 29-31, para. 4) and IVDR 2017/746 (Articles 26-28, para. 3), ensuring transparency and compliance across the industry.
EUDAMED registration is mandatory for:
- Authorized Representatives
- EU and non-EU manufacturers
- System and procedure pack producers
- Importers
Role of the Authorised Representative
If a medical device manufacturer is not based within an EU Member State, their devices may only be introduced to the Union market by appointing an authorised representative (AR). This AR will act on behalf of the manufacturer located outside the EU, facilitating their compliance with EU regulations.
This includes ensuring that all necessary documentation is in place and that the manufacturer’s products meet regulatory standards.
MDR/IVDR Article 11 outlines the key responsibilities that authorised representatives must fulfill. Gain more insights on the responsibilities and liabilities of an Authorised Representative from here.
Steps for Managing Manufacturer Data and EUDAMED Registrations
1. Establish a Written Mandate
Gather necessary documents such as the summary mandate from the manufacturer, which should detail the tasks you are authorized to perform, including the start and end dates of the agreement and the generic device groups it covers. The mandate commonly constitutes a formal agreement between the Manufacturer and the Authorized Representative (AR).
Key Components of the Written Mandate
- Authorization Details
Clear specification of the tasks and responsibilities that the AR is authorized to perform on behalf of the manufacturer.
- Duration of Agreement
The start and end dates of the mandate are to define the period during which the AR is authorized to act.
- Device Identification
Inclusion of details related to the Unique Device Identifiers (UDIs) for the medical devices covered under the mandate, specifically the UDI-DI (Device Identifier) and any associated Basic UDI-DI. This ensures clarity on which devices are included in the agreement and facilitates compliance with EUDAMED regulations.
- Generic Device Groups
Specification of the generic groups of devices that fall under this mandate, allows for streamlined management and regulatory compliance.
- Compliance Requirements
Outline of obligations related to regulatory compliance, including adherence to EU regulations such as MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), which necessitate registration in EUDAMED.
- Documentation and Reporting
Requirements for maintaining documentation related to device registration, post-market surveillance, vigilance reporting, and any updates or modifications to device information in EUDAMED.
- Communication Protocols
Procedures for communication between the manufacturer and AR, including how information will be exchanged regarding compliance status, safety issues, or regulatory updates.
- Termination Clauses
Conditions under which either party may terminate the agreement, including notice periods and responsibilities upon termination.
The mandate serves as a critical reference to ensure clarity and alignment on the scope of responsibilities and compliance requirements.
There is no need to upload the entire mandate text on EUDAMED—just a summary or key extract will do. Include the start and end dates, details of the manufacturer and authorized representative, and the list of generic device groups covered.
2. Verification of Manufacturer Compliance and Document Management
Ensure that the manufacturer has completed all necessary registrations and that their products comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the AI Act as applicable. This includes ensuring that the EU Declaration of Conformity and technical documentation are prepared, and verifying that the manufacturer has conducted the required conformity assessment procedure, where applicable (MDR/IVDR Article 11(3)(a)).
An AR is also required to maintain copies of all relevant documents and make them available to authorities upon request. This includes technical documentation, declarations of conformity, certificates, and any amendments or supplements (MDR/IVDR Article 11(3)(b)). Additionally, ARs must confirm that the manufacturer has registered the required information in EUDAMED (MDR/IVDR Article 11(3)(c)).
3. EUDAMED Registration
Acting on behalf of non-EU manufacturers, the Authorised representative must assist in the registration of non-EU manufacturer and their devices in the EUDAMED database and secure an SRN (Single Registration Number) that serves as a unique identifier within the EUDAMED system. It is the manufacturer’s responsibility to register their information and devices in EUDAMED, while the authorized representative verifies that the manufacturer has met these registration requirements. The AR acts as an intermediary, ensuring that all required documentation and data are correctly submitted to EUDAMED.
4. Ongoing Compliance Monitoring
Authorised representatives should keep abreast of any changes in regulations or device information that may affect compliance, including those introduced by the AI Act. As AI technologies become more integrated into medical devices, compliance with the AI Act will be essential for products that incorporate AI functionalities.
Regularly check that all data in EUDAMED is up-to-date. They need to be prepared to assist competent authorities with market surveillance activities by providing necessary documentation and being available for inspections.
5. Training and Standard Operating Procedures (SOPs)
Depending on your organizational structure, consider developing SOPs which explicitly integrate the role of the Authorised Representative, e.g. for complaint handling and in the event of product recalls. This can enhance compliance along the chain of economic operators and streamline operations. It is useful to share these procedures with the relevant parties in the economic operator chain and keep them up-to-date. Source.
6. Maintain Open Lines of Communication with Manufacturers
Regularly communicate with the manufacturers that they represent to ensure they understand their obligations and provide timely updates on their products.
Concluding Remarks
The Authorised Representative is not merely a figurehead but a critical partner for non-EU manufacturers navigating the complexities of entering the European market. By understanding their responsibilities as an Authorized Representative in relation to EUDAMED, ARs can effectively manage manufacturer data and ensure compliance with EU regulations.
If you’re looking for expert assistance in managing your manufacturer data and ensuring seamless EUDAMED registrations, look no further. As an experienced authorised representative, we’re here to guide you through every step of the process. Contact us today to ensure your compliance and simplify your regulatory journey.
