The EU Authorised Representative Service
It’s a Mandatory Requirement
The appointment of an EU Authorised Representative (EU REP) is a mandatory requirement for medical device manufacturers located outside the EU who wish to sell and place medical devices and in-vitro devices on the EU market.
It’s a Critically Important Regulatory Role
The EU REP plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the EU and serves as their contact person established in the EU.
Article 11 of Regulation (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR) outlines the obligations of the EU REP and introduces enhanced responsibilities. The EU Commission deem the EU REP so critically important they made the EU REP jointly and severally liable with the manufacturer for defective devices they may place on the EU market.
Experienced & Qualified
Advena has over 25 years experience as an EU REP and employs qualified individuals who possess the necessary expert knowledge of the regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.
Appointing the Right Partner is Crucial
Advena’s Authorised Representative service goes beyond the obligations of Article 11 of the MDR, IVDR, and MDCG 2022-16 guidance. We also help by providing client guidance, opinions, professional advice, and vital regulatory news updates, all designed to help clients understand regulatory compliance.
We are also a founding member of the European Association of Authorised Representatives (EAAR).
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.
For manufacturers of medical devices who fall into the above category, it is a legal requirement to appoint an EU Authorised Representative.
An EU Authorised Representative may also be known as a EUAR, EC REP, CE REP, EU REP, and also an EAR. All of these mean the same, EU Authorised Representative.
EU Authorised Representative (EU Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.
In addition, as your EU Rep Advena will
- Provide the manufacturer with a registered address in the EU, that is shown on their labelling packaging or IFU.
- Provide a point of contact between the manufacturer and EU Authorities.
- Carry out its obligations as set-out in Article 11 of both Regulation (EU) 2017/745 (The MDR) & (EU) 2017/746 (The IVDR).
- Comply with the requirements of MDCG 2022-16
- Support and assist manufacturers with their medical device and IVD device registration obligations.
- Keep on file a copy of your full technical documentation for inspection by EU regulators, upon request.
- Provide support and assistance with vigilance and help manufacturers understand their obligations concerning reporting in accordance with EU regulations.
- Provide regulatory news and updates to the manufacturer to assist them with maintaining regulatory compliance.
- Be available to consult with and support the manufacturer with issues regarding regulatory and QMS compliance.
- Carry the requisite level of product liability insurance since under EU law the EU REP is jointly and severally liable with the manufacturer for defective devices they may placed on the market.
Why Choose Advena as Your EU Authorised Representative?
Advena is one of the largest EU REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting clients to navigate the complex regulatory landscape in the EU.
- 25 years’ experience as an EU REP
- Experienced consultants to review your technical files.
- We assist and provide support with EU device registrations.
- If you need consultancy support, we have the depth of experience you can rely on.
- If you need support and guidance with vigilance issues, we are here to help.
- We are responsive, 90% of emails are replied to within 24-48 hours.
- You will receive our monthly regulatory newsletter that helps you keep up to date with the changes in regulations and standards.
- We are available to answer questions & queries as part of our service.
- We offer a premium service at a competitive price.
Years of experience
With over 25 years of experience as an EU Authorised Representative Advena is the perfect choice for your business. It makes sense for you to engage with an experienced regulatory team. Our service has been developed to specifically support the needs of start-ups and small to medium sized manufacturers, to help them successfully enter the EU market.
Personal approach
We have a team of professional business administrators who provide a personal approach and place the needs of our clients at the very top of our priorities while also recognising that the applicable EU regulations must be complied with. Just take a look at our Client Testimonials page.
Great Responsive support
We also understand that clients need to be able to reach out for help and advice and how important being responsive is, Advena is committed to supporting our clients and is always available to answer client’s questions and queries, and this is included as standard in our service. In fact, our client feedback survey found that 90% of emails were replied to within 24-48 hours.
The 6 simple Steps to Appoint Advena
Fully professional and supportive
I have worked with Advena on the Regulatory side of our business now for more than 10 years. The service provided during this time has… “Fully professional and supportive”
Well informed
Advena have acted as the EU representative for Aus Systems Pty Ltd since 2005. I have always found John and his team quick to respond… “Well informed”
Quality of services
I have used Advena as part of another company and I have contracted them again for the quality of services and reasonable fees. The newsletter… “Quality of services”
Very positive experience.
Always responsive and willing to work with us. Has gone above and beyond on a number of occasions, and that has been very helpful when… “Very positive experience.”
Professional service and quick response
We have been using Advena Ltd. as our EU Authorised Representative since 1998 and have been very pleased with the professional service and quick response… “Professional service and quick response”
For More Information Concerning Our EU REP Service that
- Complies with Article 11 of the MDR & IVDR.
- Meets the requirements of MDCG 2022-16.
- Is certified to ISO13485.
- Is cost effective.
- Offers regulatory guidance and opinion.
- Answers your questions in a responsive manner.
- Allows you to benefit from our extensive experience and knowledge.
- Provides support and assistance with EU device registrations.
Contact us for a free quotation/proposal.
