ANSWERED ON THIS PAGE:
- What are the responsibilities of an EU Authorized Representative (EC REP)?
- Can I appoint a distributor as my representative?
- What happens if I want to change my EC REP?
- How has Brexit affected EU Authorized Rep requirements?
Interested in obtaining CE certification to sell your medical device or in vitro diagnostic (IVD) device in Europe? If your company does not have a physical location in Europe, you are required to appoint an Authorized Representative (also referred to as an EC REP or AR) to represent your company to European authorities. You must retain an EC REP as long as you sell your devices in Europe.
What is the role of an EU Authorized Representative?
Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:
- Assist with certain medical device and IVD registrations, as required.
- Be identified on your product labeling throughout Europe.
- Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request.
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors.
- Provide ad hoc consulting hours to our EU AR clients, which grants them access to our global regulatory consulting team for direct strategic consulting support.
It is possible to appoint a distributor as your Authorized Representative in Europe; however, it is not recommended because most distributors are not prepared to fulfill the mandatory responsibilities of the EC REP. Instead, select an independent representative that focuses on regulatory affairs, rather than sales and marketing. Read more about the benefits of hiring an independent firm to act as your EC REP in Europe.
Why choose Emergo as your European Authorized Representative?
Emergo is the largest EU AR for medical devices and IVDs, representing more than 1,000 device companies worldwide. We offer a new premium EU AR service designed for manufacturers looking for more than just an EU AR. Emergo's EU AR service is structured to serve as a global regulatory partner. As your EU AR partner:
- Our experienced consultants will review your Technical File, register your medical device or IVD, as required, and respond to any questions or concerns from the Competent Authorities.
- You will have secure online access to all your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines, and more.
- Our vast expertise with European regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
- We send frequent updates to all our Authorized Representation clients with important regulatory updates focused on Europe.
- In addition to our European offices, we maintain offices in the US, UK, Canada, Japan, Korea, Brazil, and many other places worldwide. We can serve you efficiently regardless of your time zone.
Common questions regarding EU Authorized Representation for medical device and IVD companies
What is the role of the Authorized Representative under the MDR and IVDR?
Authorized Representatives take on more risk and liability under Europe's Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR). The EC REP will be held jointly and severally liable for defective medical devices or IVDs, so you can expect that your representative will monitor your compliance more thoroughly.
How has Brexit affected representation requirements for device companies selling in the UK and the EU?
Following the UK’s departure from the European Union, EU and non-EU device companies must appoint a UK Responsible Person (UKRP) to continue selling in the UK. Further, UK-based companies need an EU-based AR to continue selling in the EU. Contact us to learn more about Brexit transition consulting services.
What happens if we do not appoint an EC REP?
Your Notified Body requires appointment of an EC REP before they will issue a CE certificate. Compliance to the MDR or IVDR is mandatory for any device placed in the EU market; therefore, engaging and identifying your chosen representative is essential. If you do not appoint a rep, your products may be stopped at the border.
Do we have to put the name of the Authorized Representative on our labeling, packaging and IFUs?
Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use. The name and address of the Authorized Representative should be shown next to the official EC REP logo.
Can a Competent Authority inspect my Authorized Representative?
Yes. A Competent Authority can inspect an Authorized Representative at any time to determine if they understand their role, have direct access to client documentation such as the Technical File/Design Dossier and have processes in place to meet its obligations as an Authorized Representative.
Can I change Authorized Representatives after I appoint one?
Yes. You may switch your EC REP without invalidating your product approvals in Europe. However, keep in mind that because your EC REP must be printed on your labeling, switching can be somewhat costly as you will need to change labeling and deal with the issue of products that are already on the market.