When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States, compliance with EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Device Regulations (IVDR) becomes paramount. To achieve this, they must designate a European Authorized representative EAR situated within EU. This EAR serves as the intermediary between the manufacturer and the national competent authorities.
Understanding the European Authorized Representative (EAR)
The European Authorized Representative (EAR) is an individual or legal entity within the EU, authorized in writing by a foreign manufacturer to act on their behalf and fulfill obligations under the EU MDR or EU IVDR. The terms EUAR, EC REP, CE REP, EU REP, and EAR are interchangeable and synonymous with EU Authorized Representative. It's important to note that Notified Bodies require the appointment of an EC REP before issuing the CE certificate. Failure to appoint a representative can result in product delays at EU borders.
EARs are responsible for both pre-market and post-market compliance and regulatory issues on behalf of manufacturers. Notably, the authorized representative can be held liable for defective devices alongside the manufacturer if the latter fails to comply with its obligations under the Regulations and is not located in the EU. Consequently, foreign manufacturers can expect a thorough due diligence and scrutiny process when selecting an Authorized Representative partner.
Article 15 of MDR 2017/745 outlines the requirements for the EAR concerning the Person Responsible for Regulatory Compliance (PRRC). Each EAR must maintain, on an ongoing and permanent basis, at least one person with the necessary expertise in EU medical device regulatory requirements to oversee compliance.
Obligations and Responsibilities of an EAR
Most of the obligations and responsibilities of European Authorized Representatives are outlined in Article 11 of MDR 2017/745:
The EAR must possess a written mandate signed by the manufacturer and the EAR
The manufacturer must enable the EAR to perform tasks such as verifying the availability and currency of the EU declaration of conformity and technical documentation, ensuring that technical documentation and relevant certificates are retained for the specified durations, registering on EUDAMED to obtain a single registration number (SRN), and passing on requests for information to the manufacturer and Competent Authorities (CA).
The EAR must also verify UDI compliance, cooperate with CAs on preventive or corrective actions, promptly inform the manufacturer of device-related complaints or reports, and terminate the mandate if the manufacturer violates its obligations under the Regulation.
Additionally, the EAR ensures that the manufacturer's technical documentation aligns with the corresponding conformity procedure and authorizes the inclusion of the EU AR's name and address on manufacturer labeling and documentation.
An agreement (mandate) detailing the obligations of both manufacturer and AR throughout the product's EU market presence must be executed.
The EAR provides copies of the Technical File or EU Declaration of Conformity to Competent Authorities upon request and supports Incident and Field Safety Corrective Action (FSCA) reporting.
Manufacturers cannot delegate certain obligations, such as design, manufacture, risk analysis, clinical evaluation, technical documentation, declaration of conformity, or UDI compliance.
Appointing a Distributor as an EAR: Considerations
Appointing a distributor as your Authorized Representative in Europe is possible but not advisable due to potential conflicts of interest and a distributor's limited readiness for regulatory responsibilities. Instead, it is preferable to choose an independent representative specializing in regulatory affairs.
Considerations when contemplating a distributor as an authorized representative:
The authorized representative must be granted unrestricted access to complete technical documentation and provide access to competent authorities across EU member states.
An authorized representative must stay informed about legal regulations changes and provide timely warnings to the manufacturer.
The authorized representative must have the capability to efficiently represent the manufacturer to Competent Authorities.
The EU Authorized Representative should have detailed knowledge of individual EU member state regulations.
The Authorized Representative must remain neutral in all actions, including competing distributors.
EAR and Device Labeling
The name and address of the Authorized Representative (AR) must be included on product labels, outer packaging, and/or Instructions for Use (IFU). While not mandatory for IFU, including AR information is strongly recommended. To simplify translation efforts, positioning AR information alongside the EC REP symbol is advisable.
EAR and Inspections
Competent Authorities have the right to inspect an Authorized Representative at any time to assess their understanding of their role, access to client documentation, and compliance with obligations.
Change Management of an EAR
Changing your EC REP is possible without jeopardizing product approvals in Europe. However, it incurs expenses related to abelling modification and addressing products already in circulation. Article 12 of the MDR and IVDR outlines the process for transferring an EU representative.
Considerations during the transition:
Manufacturers must update abelling
Document termination and initiation dates for AR relationships.
Ensure the former AR conveys complaints received regarding devices placed on the market before the transition.
Formally outline these aspects in an agreement endorsed by all involved parties.
EAR as UKRP and CH-REP
For the UK market, manufacturers must appoint a UK Responsible Person due to the UK's withdrawal from the EU. Additionally, a Swiss Authorized Representative (CH-REP) is required for Switzerland following the lapse of the Mutual Recognition Agreement.
Although a single entity has the capability to serve as your EU Authorized Representative, UK Responsible Person, and Swiss Authorized Representative, it is imperative that this entity possesses a physical presence and registered business in each respective region. At Artixio, we offer comprehensive support to our clients in all three markets, facilitating a streamlined and efficient process.
EAR and EUDAMED Database
EARs must register in the EUDAMED and obtain a single registration number (SRN), which can be verified in a public database. European Authorities commonly communicate with EARs, not directly with non-European manufacturers. Therefore, AR information must be displayed on labeling, packaging, or instructions for use. EARs play a pivotal role in communicating with various parties across Europe regarding device-related queries and concerns.
Choosing the right EAR is a critical decision for manufacturers seeking to enter or maintain their presence in the EU market. It's essential to opt for a partner with the expertise, neutrality, and commitment to regulatory compliance. While the process of designating an EAR can be intricate, it is a necessary step for accessing the vast and lucrative EU market.
If you are a medical device or in-vitro diagnostic manufacturer looking to navigate the EU regulatory landscape effectively, partner with us. Our team of experts specializes in regulatory affairs and can guide you through the intricacies of compliance, ensuring a seamless market entry or continuation of your operations in the European Union.
Contact us today to discuss how our European Authorized Representative services can support your business goals, streamline compliance, and open doors to the thriving EU market. Don't let regulatory complexities hold you back; take the next step toward success in Europe with our trusted expertise.
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