EU Authorised Representative
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EU Authorised Representative Services
If you are a manufacturer based outside the EU and intend to sell a Class I, II or Class III medical device in the European Union (EU) then you may require an EU Authorised Representative. Read on to learn about our European Authorised Representative service for medical devices (also known as EU MDR Authorized Representative).
Contents
What is an Authorised Representative in the EU?
Who can be an EU Authorised Representative?
What is the European Authorised Representative Service?
Key responsibilities of an EU Authorised Representative
Why choose us as your EU Authorised Representative?
About our EU Authorised Representative Services
What is an Authorised Representative in the EU?
The EU Authorised Representative is a natural or legal person appointed by a medical device manufacturer, not established in the EU, to act on their behalf in matters relating to compliance with Medical Devices Regulation (EU MDR).
Who can be an EU Authorised Representative?
The EU Authorised Representative must be knowledgable and experienced in EU medical device regulation and based in an EU member state. They should have the capacity to represent a non-EU manufacturer with the lawful placement of medical devices on the EU market.
What is the European Authorised Representative Service?
The European Authorised Representative Service enables non-EU businesses to market medical devices within the European Union (EU). This representative is usually a legal entity or company located in an EU market. They act on behalf of the non-EU business regarding medical device regulations (EU MDR). A European Authorised Representative is the same as the EU representative.
Our EU Authorised Representative Service
Choose our European Authorised Representative service for your medical device
We specialise in assisting medical device manufacturers outside the EU in meeting their regulatory obligations by acting as their dedicated EU Authorised Representative. Our comprehensive services ensure compliance with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). Partner with us to navigate the complex regulatory landscape and successfully bring your medical devices to the European market.
Contact us to learn more
Contact us today to learn more about our European Authorized Representative Services by submitting the form below or email info@medicpro.london
Key responsibilities of an EU Authorised Representative
Communication with Competent Authorities
The Authorised Representative serves as a contact point for EU Competent Authorities. They assist in communication and coordination between the manufacturer and the relevant regulatory authorities.
Ensuring Compliance
The EU Authorized Representative ensures the manufacturer complies with MDR or IVDR requirements. They actively verify that all necessary conformity assessments are conducted, technical documentation is complete, and other regulatory obligations are fulfilled.
Maintaining Documentation
The EU Representative is responsible for maintaining required documentation, such as the EU Declaration of Conformity and technical documentation, ready for inspection by Competent Authorities.
Cooperation with Importers and Distributors
The AR collaborates with importers and distributors to make sure that the devices placed on the market comply with regulatory requirements.
Post-Market Surveillance
The AR participates in post-market surveillance activities and informs the manufacturer about serious incidents and field safety corrective actions.
Why choose us as your European Authorised Representative?
Expertise and Experience
Our experts have extensive experience with the regulations and stay up-to-date with the latest EU regulations, ensuring that your products comply with all legal requirements.
Efficient Communication with Competent Authorities
As your dedicated Authorised Representative, we serve as the primary point of contact with EU Competent Authorities. Our streamlined communication processes facilitate quick and efficient interactions, helping you navigate regulatory hurdles seamlessly.
Comprehensive Compliance Support
We understand the intricacies of EU MDR and IVDR compliance. Our services cover a wide range of tasks, including verifying conformity assessments, maintaining essential documentation, and ensuring ongoing compliance with evolving regulations.
Tailored Solutions for Your Business
Each manufacturer and their products are unique. We offer customized solutions tailored to your specific needs. Whether you’re a small startup or a well-established company, our services are designed to fit your business model. They ensure compliance at every stage.
About our European Authorised Representative Services
Regulatory Consultation
Before you enter the EU market, our experts offer thorough regulatory consultations. We guide you through applicable regulations, clarify the steps required for compliance, and ensure a smooth market entry process.
Conformity Assessment Support
Our team assists in conducting comprehensive conformity assessments, ensuring that your medical devices meet the stringent requirements set by the EU authorities. We work closely with manufacturers to identify and address any potential compliance gaps.
Document Management
Maintaining accurate and up-to-date documentation is critical for EU MDR and IVDR compliance. We manage essential documents like the EU Declaration of Conformity and technical documentation for you, ensuring readiness for regulatory inspections.
Post-Market Surveillance
Our services extend beyond market entry. We actively participate in post-market surveillance activities, keeping a vigilant eye on the performance of your medical devices in the EU market. In case of any incidents, we promptly inform you and assist in implementing necessary corrective actions.
Collaboration with Importers and Distributors
Building strong partnerships with importers and distributors is crucial for successful market penetration. We collaborate actively with these stakeholders on your behalf. This ensures that your products are distributed and handled in compliance with EU regulations.
Updates on Regulatory Changes
The regulatory landscape is dynamic, with changes occurring regularly. We keep you informed about any amendments or updates to EU regulations, enabling you to adapt swiftly and maintain continuous compliance.
Contact us today
Get in touch to learn more about our European Authorized Representative Services
FAQ
1. Do I need an EU Authorised Representative?
If you intend to sell medical devices in the European Union (EU) but do not have a base in one of the EU’s 27 member states then you may require an European Authorised Representative. This representative handles compliance with EU regulations, ensuring your products meet safety and regulatory standards. Without one, you cannot legally sell a medical device.
2. What are the EU Authorised Representative requirements?
Manufacturers outside the European Union (EU) must appoint an EU Authorized Representative (also known as European Authorized Representative) to place medical devices in the EU market. This appointment is a key requirement of the EU Medical Device Regulation.
3. Does a US manufacturer require a European Authorized Representative?
US manufacturers planning to place a medical device in the EU must appoint an EU Authorized Representative (also known as EU MDR European Authorized Representative). This is a key requirement under the EU Medical Device Regulation.
4. Are EU Authorised Representatives mandatory?
Yes. Manufacturers that place a medical device in the EU must appoint a European Authorized Representative. This appointment is a key requirement of the EU Medical Device Regulation.
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