Who represents you as a non-European manufacturer within the EU? The EC-REP (or EU-REP), the authorized representative according to Article 11 of the European Regulations for Medical Devices (EU) 2017/745 (MDR) or In Vitro Diagnostics (EU) 2017/746 (IVDR).Swiss medical device manufacturers or in vitro diagnostic manufacturers who wish to place their products on the EU market must appoint an EU-based representative. EU-REP, European Community Representative (EC-REP), European Authorized Representative (EAR), European Authorized Representative for medical devices and in vitro diagnostics: The names for the EU Authorized Representative are diverse, but their tasks are clearly defined.Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) apply to all medical devices or in-vitro diagnostics (IVDs) placed on the market in the EU. This also includes medical devices or in vitro diagnostics manufactured by manufacturers based outside the EU. For these manufacturers, it is necessary to appoint an EU Authorized Representative (EU-REP, EC-REP) to act on their behalf and to fulfill the obligations to be assigned by the manufacturer to the Authorized Representative with respect to compliance with the MDR or IVDR.Meet EU regulatory requirements with ease - Talk to our EU REP experts!
EC-REP: Requirement for EU Market Access for Swiss Manufacturers
Without an EU authorized representative, Swiss medical device manufacturers or in vitro diagnostic manufacturers are not allowed to sell their products in the EU. An EC-REP is therefore a mandatory requirement for access to the EU market.
What are the tasks and responsibilities of the EU Authorized Representative/EC-REP?
The rights and responsibilities of the EU Authorized Representative are defined in Article 11 of the MDR and are detailed through a cooperation agreement between you and us as the EU Authorized Representative. In general, as the EU Authorized Representative (EC Rep), we undertake the following tasks:
- Taking over the responsibilities towards the EU authorities, including monitoring compliance with all relevant regulations.
- Review of Declarations of Conformity and Technical Documentation, as well as conformity assessment procedures for the European market.
- Take over the duties to retain the necessary documents.
- Communication with authorities during inspections regarding product conformity.
- Cooperation with authorities on all preventive or corrective actions and ensuring the collaboration of all involved parties.
- Immediate communication to you as soon as irregularities are detected.
- Verification of compliance with registration requirements for unique product identification and registration of the relevant products.
What advantages does an EU Authorized Representative/EC-REP offer you?
Access to the EU market: You gain access to the EU market without being established in the EU yourself. This facilitates the distribution of your products in the EU and thus increases your market opportunities.Regulatory compliance:The EU Authorized Representative (EC-REP) ensures that you meet all regulatory requirements and therefore MDR or IVDR compliance is guaranteed. This minimizes the risk of regulatory violations, penalties, and product recalls.Expertise: an EU Authorized Representative (EC-REP) has specialized know-how and experience in EU regulation and can provide you with valuable support and advice on regulatory issues and challenges.Efficiency: You can reduce administrative tasks and EU regulatory compliance costs because the EU Authorized Representative (EC-REP) takes over these tasks.
What else needs to be considered when importing into the EU?
Importers are required to register with the European Database for Medical Devices (EUDAMED), while distributors are excluded from this requirement. It is important to note that organizations acting as both manufacturers and importers must fulfill their registration obligations in both roles. Make sure your organization meets all registration requirements.
Metecon as your EU Authorized Representative/EU-REP: Get a three-way benefit from our know-how
Expertise and Experience: We are widely positioned in terms of expertise. Our teams have the necessary knowledge and experience for all regulatory requirements of your product(s). We find the best way for you and help you identify and solve potential problems at an early stage.Time and Cost-savings: you save time and money because you do not have to invest in the necessary regulatory expertise and infrastructure yourself.Flexibility: More than 60 permanent team members are at your disposal for all regulatory opportunities. We are there for you whenever you need us!Accelerate your EU market access with our EU-REP services - Contact us now!