European Authorised Representative
A European Authorised Representative (EAR) is a crucial entity for non-EU manufacturers looking to market their medical devices within the European Union. The EAR acts as a liaison between the manufacturer and the European regulatory authorities, ensuring that the manufacturer's products comply with EU regulations, such as the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
EU Representative for MDR and IVDR
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the role of the European Authorized Representative (EAR) is clearly defined with specific obligations. Non-EU manufacturers must appoint a European Authorized Representative before they can market their medical devices and in vitro diagnostic devices (IVDs) in the European Union. The EAR serves as the regulatory liaison between the manufacturer and the EU Competent Authorities.
Responsibilities of the EU Representative:
Regulatory Compliance: The EU Representative ensures that the manufacturer’s technical documentation is accurate and compliant with MDR and IVDR requirements, following the correct conformity assessment procedures.
Documentation Management: The EAR is responsible for maintaining copies of the technical documentation file for a minimum of 15 years, ensuring that it is available for review by Competent Authorities when requested.
Labeling and DOC Authorization: The EU Representative grants authorization to include their name and address on the device label and Declaration of Conformity (DOC), ensuring that all labeling requirements are met.
Mandate Agreement: Executes a formal agreement (mandate) with the manufacturer, clearly outlining the obligations of both parties throughout the product’s lifecycle in the EU market.
EUDAMED Registration: Assists with applying for, reviewing, and verifying the manufacturer’s EUDAMED Single Registration Number (SRN). The EU Representative ensures that the manufacturer fulfills all EUDAMED registration obligations.
Technical Documentation Access: Provides Competent Authorities with access to the manufacturer’s technical documentation upon request, ensuring transparency and compliance.
Vigilance and Incident Reporting: Plays a key role in handling complaints, serious adverse events, and reporting incidents to the Competent Authorities and Notified Bodies, as required. The EAR also supports the manufacturer in executing Field Safety Corrective Actions (FSCA) in collaboration with importers and distributors.
Post-Market Surveillance: Monitors post-market data, ensuring that any issues are promptly reported and addressed in compliance with MDR and IVDR regulations.
Roles and Responsibilities of Manufacturers
Designation of EU Representative: Non-European manufacturers must appoint a single European Authorized Representative (EAR) before they can import and sell medical devices or in vitro diagnostic devices within the European Union. This designation is a mandatory step for market access.
Authority of EU Representative: The designation of the EAR is formalized through a written agreement. This agreement grants the EAR the authority to represent the manufacturer for all devices within the same generic device group. The agreement must be mutually signed and approved in writing by both parties.
Tasks of the EU Representative: The EAR performs tasks as specified in the mandate agreed upon with the manufacturer. The Representative is required to provide a copy of this mandate to the Competent Authority upon request. The mandate must stipulate that the manufacturer authorizes the EAR to:
Documentation Management: Maintain a copy of the technical documentation, EU Declaration of Conformity, and, if applicable, relevant certificates (including amendments and supplements) for the period specified in Article 10(8) for review by Competent Authorities.
Registration Compliance: Ensure compliance with registration obligations outlined in Article 31, and verify that the manufacturer has met the registration requirements specified in Articles 27 and 29.
Information Provision: Upon request from a Competent Authority, provide all necessary information and documentation to demonstrate the device's conformity in an official Union language determined by the concerned Member State.
Sample Requests: Forward any requests for samples or access to a device made by a Competent Authority in the Member State where the EAR is registered, and ensure that the Competent Authority receives the samples or access as required.
Collaboration on Corrective Actions: Collaborate with Competent Authorities on any preventive or corrective actions necessary to eliminate or mitigate risks presented by devices.
Incident Reporting: Promptly inform the manufacturer of any complaints or reports received from healthcare workers, patients, or users concerning suspected incidents involving a designated device.
Termination of Mandate: Terminate the mandate if the manufacturer fails to meet its obligations under the Regulation and notify the Competent Authority of the Member State where the EAR is registered, as well as the Notified Body involved in the device's conformity assessment, if applicable.
Non-Delegable Mandate: The mandate as specified in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11), and (12) cannot be delegated to another party.
Liability for Defective Devices: If the manufacturer is not established in a Member State and fails to meet its obligations under Article 10, the EU Representative is legally liable for defective devices, jointly and severally, with the manufacturer.
Notification of Termination: An EU Representative who terminates their mandate for reasons specified under paragraph 3, point (h), must immediately inform the Competent Authority of the Member State where the EAR is registered, and, where applicable, the Notified Body involved in the device’s conformity assessment, about the termination and the reasons behind it.
Interpretation of Competent Authority Reference: Any reference to the Competent Authority of the Member State where the manufacturer has its registered place of business shall be interpreted as a reference to the Competent Authority of the Member State where the designated EU Representative is established.
EU Representative Agreement and Mandate
The terms "EU Representative Agreement" and "Mandate" are often used interchangeably, though they can carry slightly different connotations depending on the context. In the realm of appointing an EU Authorized Representative for medical devices, these terms typically refer to the same contractual relationship between the foreign manufacturer and the EU Representative.
EU Representative Agreement: This is the formal contract between the manufacturer and the European Authorized Representative (EAR). It details the responsibilities, duties, and obligations of both parties concerning regulatory compliance, communication with EU authorities, and other essential aspects related to the marketing and sale of medical devices within the European Union.
Mandate: The mandate is the authorization that the manufacturer grants to the European Representative, allowing the EAR to act on the manufacturer’s behalf within the EU market. This mandate empowers the EU Representative to carry out specific tasks and responsibilities as outlined in the agreement. It effectively delegates certain regulatory and compliance-related functions to the EAR.
While "EU Representative Agreement" and "Mandate" may seem like distinct terms, they both generally refer to the same contractual arrangement. This arrangement outlines the roles and responsibilities of the manufacturer and the European Authorized Representative, ensuring compliance with EU regulations for medical devices.
Formalities for changing current EU Representative
When changing your current EU Authorized Representative (E.A.R), the process must be handled with precision to ensure compliance with the EU MDR and IVDR regulations. As outlined in Article 12, the following formalities should be clearly defined in an agreement involving the manufacturer, the outgoing EU Authorized Representative, and the incoming EC Representative:
Registered Address: Ensure the incoming E.A.R provides a registered address in the EU to be mentioned on the product packaging.
Technical Documentation: The new E.A.R must keep the updated technical documentation available for inspection by the competent authorities.
Representation: The incoming Representative must effectively represent the manufacturer in front of the European Commission, Notified Bodies, and end-users.
Device Registration & Certification: The new E.A.R should handle device registration and manage the issuance of the EU Free Sale Certificate.
Incident Management: They must take responsibility for managing incidents reported by healthcare professionals, patients, and users.
Regulatory Compliance: The new Representative must ensure the manufacturer's compliance with regulatory news and updates.
Importer & Manufacturer Registration: They should verify and update the registration of the importer and manufacturer within the EU.
Ongoing Support: The E.A.R must provide continuous consultation and support to the manufacturer.
Mandate Termination: The agreement should include provisions for terminating the mandate if the manufacturer fails to meet MDR/IVDR obligations.
Post-Market Surveillance: Review and provide guidance on PMS, PMCF, and PSUR requirements if needed.