EUROPEAN AUTHORIZED REPRESENTATIVE - MEDICAL DEVICES

In order to place devices on the EU market, manufacturers with an Authorized Representative based in the EU will need to establish a new Authorized Representative in an EU country and complete the necessary registrations of their products.

International Associates offer the Service as your trusted partner for navigating the complex landscape of medical device regulations in the European Union (EU). As the regulatory landscape continues to evolve, compliance with the Medical Device Regulations (MDR) is paramount for manufacturers seeking to bring their products to market. Our team specialises in providing comprehensive solutions, including acting as an EU Authorized Representative, to ensure your products meet the rigorous standards set forth by the EU regulatory authorities. With our expertise and dedication to excellence, we strive to streamline the regulatory process, allowing you to focus on innovation and bringing life-changing medical devices to patients worldwide. Explore our services and discover how we can support your journey towards regulatory compliance and market success

Our objective is to offer fast, efficient, and cost-effective services, ensuring your products meet the rigorous standards set forth by EU regulatory authorities. With our team of seasoned experts, we simplify the regulatory process, allowing you to concentrate on innovation and the development of groundbreaking medical devices that enhance patient care worldwide. We have a 5-day turnaround on technical file reviews.

We also offer the service of completing the registration of your products if required.

Whether you're a startup breaking into the EU market or an established manufacturer seeking to maintain compliance, our dedicated team is committed to delivering unparalleled support and guidance every step of the way. Explore our range of services and discover how International Associates Service can accelerate your journey towards regulatory compliance and market success.

REGULATING MEDICAL DEVICES (EUROPE)

• You can read more information on the UK Gov web site here about what is actually required.

  GOV.UK

• However to summarise:

  A new role – the UK Responsible Person – has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market

  You can read more about the UK Responsible Person’s obligations in regulation 77 (for medical devices) and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).

CHANGING YORU AUTHORISED REPRESENTATIVE

• Changing your Authorized Representative is a fairly straightforward process. Article 13 of the Medical Device Regulation 2017/745 gives full details of how this can be done.
• First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).

• To be compliant, the manufacturer should address the following aspects:

  The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.

  The date until which the manufacturer can show the outgoing AR on the information or promotional material.

  The transfer of documents, including confidentiality aspects and property rights.

  The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.