European Authoritative Representative Definition

For non-EU medical device manufacturers seeking to enter the European market, appointing an EU Representative (EU Rep) is a crucial regulatory requirement. The role of an EU Rep is to act as a liaison between the manufacturer and the European regulatory authorities, ensuring compliance with EU regulations.

At CERT3Global, we provide comprehensive EU Representative services to help you seamlessly navigate the regulatory landscape and gain market access in the European Economic Area (EEA).

European Union Authorized Representative (EU Rep) is a legal entity based within the EU(or registered in the EU). EU Rep can be a person or a company (like Cert3global) who acts on behalf of a non-EU manufacturer as a ‘regulatory representative’ and a crucial point of contact between the non-EU-based Manufacturer and European Authorities.

We act in agreement with the manufacturer and have access to full technical documentation and are kept informed of any changes in Legal regulations.

Responsibilities of EU Representative

  • Assist with device registration and other formalities, when needed
  • Be identified on the device labeling, packaging, and Instructions For Use as the official Authorized Representative.
  • Assist with the incident and Field Safety Corrective Action (FSCA)reporting in coordination with Non-EU Manufacturers and Distributors.
  • In case of any defectiveness in the medical or IVD device, The EU Rep will be held legally liable along with the manufacturer.
  •  Hence it is crucial to appoint a competent entity possessing the required skillset & experience to monitor the whole compliance process with care.
  • Competent Authorities can inspect them to determine their relevant understanding and access to Technical Documentation, and have the right processes in place to meet the obligations.

Additional Information

Why Appointing an EU Authorized Rep is Required for Medical Devices?

Non-EU Manufacturers can only market their medical or In Vitro Diagnostic medical devices after appointing an EU Rep as per MDR (Medical Device Regulatory) 2017/745 & 746. They assist in the device registration process and keep compliance documents with them for 10 (or more ) years. Verify EU Declaration of Conformity and technical files.The EAR must receive an agreement with the manufacturer and act as per that.

Can You Appoint Your Distributor as an Authorized Person?
One of the responsibilities of the EU Authorized Representative is to protect the interests of the manufacturer they represent. Hence it is important to keep this in consideration when choosing one for your respective organization. A distributor may not be able to make independent decisions in your organization’s Interests every time and here are some arguments to support this:

  • Heavy Reliance on distributors as your sales will depend on their activities & commitment. Also, other important aspects like promotions, pricing, or customer interactions will be under their control.
  • The Market Access of the manufacturer will be limited to the distributor’s network and they will miss out on other opportunities.
  • If the distributor also sells competing products, then making sure that they will protect the interests of a particular manufacturer is difficult.
  • Financially, if the distributor takes a significant cut from the sales, then the manufacturer will miss out on their margins, especially if they are a small company.

Hence, keeping the above points in consideration, it is in the manufacturer’s best long-term interest to hire independent Agency Consultants who are not in the business of distributing medical devices. Cert3global is a team of one such independent Agency that acts in the best interests of non-EU manufacturers. We have the expertise and experience to help many in their complete compliance process.

Why Choose Cert3global as Your European Authorized Representative?

  • Cert3gobal offers Exhaustive support to non-European manufacturers who wish to enter and upkeep their presence in the EU Market with their Medical or IVD (In Vitro Diagnostic) Device.
  • Our Experienced and Expert regulatory consultants will review your Technical documents, register your device, and represent your best interests to the competent authorities.
  • We have proper processes in place utilizing technology in all steps of the process, right from the digital safety of documents and updating your team regarding the latest regulatory and market updates.
  • We offer specifically medical device regulatory consulting services (unlike Distributors and legal Firms) to many manufacturers worldwide (EU, USA & UK), hence our diverse experience will help you get the best quality service out of your money.

Hiring us as your EU Authorized Representative will be in the best interest of your organization’s long-term market success in the Union. Send us a query to know more. Let’s collaborate to start your market journey in the world’s one of the most valuable medical device markets which generates $122 bn (2020) each year as revenue and accounts for 30% of the market worldwide.

Understanding the Role of an EU Representative

An EU Representative, also known as an Authorized Representative, is a legally mandated entity based within the EU. This entity is responsible for ensuring that non-EU manufacturers comply with the relevant EU directives and regulations. The EU Rep’s responsibilities include:

  • Product Registration: Registering the manufacturer’s products with the relevant EU regulatory bodies.
  • Technical Documentation: Holding and maintaining the manufacturer’s technical documentation for regulatory review.
  • Compliance Verification: Ensuring that the product conforms to applicable EU regulations, such as the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
  • Post-Market Surveillance: Facilitating communication between the manufacturer and EU authorities for vigilance reporting and post-market surveillance.
  • Labeling Requirements: Ensuring that the product labeling and packaging meet EU standards.
  • Recall Coordination: Assisting with the coordination of product recalls and field safety corrective actions if necessary.

Why an EU Representative is Essential

Non-EU manufacturers are legally required to appoint an EU Rep to access the European market. This appointment not only ensures regulatory compliance but also enhances the credibility and marketability of your products. An EU Rep serves as your point of contact within the EU, facilitating smooth communication with regulatory authorities and helping to navigate the complexities of the EU regulatory environment.

Our Comprehensive EU Representative Services

We offer a full spectrum of EU Representative services tailored to the unique needs of medical device manufacturers. Our experienced team is dedicated to ensuring your products comply with EU regulations and achieve successful market entry.

1. Product Registration and Documentation

We handle the entire product registration process, ensuring your products are properly registered with the relevant EU authorities. Our team meticulously reviews and maintains your technical documentation, ensuring it meets all regulatory requirements and is readily available for inspection by regulatory bodies.

2. Regulatory Compliance Support

Our experts provide comprehensive support to ensure your products comply with all applicable EU directives and regulations. We assist with conformity assessments, prepare the necessary declarations, and verify that your product labeling and packaging meet EU standards.

3. Post-Market Surveillance and Vigilance

We facilitate effective post-market surveillance by monitoring product performance and managing vigilance reporting. Our team ensures timely communication with EU authorities regarding any adverse events, product recalls, or corrective actions, helping you maintain compliance throughout your product’s lifecycle.

4. Labeling and Packaging Review

We conduct thorough reviews of your product labeling and packaging to ensure they comply with EU requirements. This includes verifying that all necessary information, such as CE marking, manufacturer details, and safety instructions, is accurately and clearly presented.

5. Recall and Corrective Action Coordination

In the event of a product recall or field safety corrective action, our team provides expert guidance and coordination. We assist with developing and implementing effective recall strategies, ensuring prompt and efficient communication with EU authorities and stakeholders.

Why Choose us as Your EU Representative?

  • Expertise and Experience: Our team has extensive experience in EU regulatory compliance, ensuring accurate and efficient support for your products.
  • Comprehensive Services: We offer a full range of EU Representative services, providing end-to-end support for your regulatory needs.
  • Dedicated Support: Our commitment to excellence ensures personalized and responsive service, tailored to your specific requirements.
  • Market Access: With our expert guidance, you can confidently navigate the EU regulatory landscape and achieve successful market entry.