EU AR services for Medical Devices

By becoming your EU MDR Authorised Representative, AR Experts, part of Certification Experts, will represent you as your EC REP for Medical Devices on the EU market. We can be named on your packaging within 24 hours upon receiving a signed agreement. With over 25 years of experience, our team of 15+ experts will help you to obtain access to the EU market and act as your EC REP.


A quick overview of this page

EC REP Definition

The EU legislations concerning Medical Devices demand that a manufacturer based outside of the EU should appoint an EC REP if the manufacturer wants to sell their Medical Devices on the EU market. An EC REP acts on behalf of the manufacturer and ensures that the devices being sold on the EU market comply with the EU Medical Device compliance legislations – so an Authorised Representative, but specifically for Medical Devices. This concerns Medical Devices that are sold either directly or via e-commerce (online), or through a fulfilment service provider.

Challenges an EC REP can solve for you

As you need an EC Rep within the EU, it might be difficult to find a suitable and trustworthy Representative who is willing and able to take on the hefty responsibilities. A competent EC Rep will bear many responsibilities, such as: registering your (the manufacturer’s) devices with the authorities, verifying the conformity assessment process, ensuring the availability of technical documentation, handling requests from the authorities and cooperating with them.

How AR Experts can help

AR Experts, part of Certification Experts, is registered in the EU and can therefore act as your needed EC REP. Once you have assigned us as your EC REP, part of your responsibilities as a manufacturer will be outsourced to us. The aforementioned challenges will no longer be of concern to the manufacturer: the AR will register your (the manufacturer’s) devices with the authorities, verify the conformity assessment process, ensure the availability of technical documentation, handle requests from the authorities, and cooperate with them.

Who We Serve

EC Rep

Trust AR Experts to be your EC REP for your Medical Devices

What is EC REP?

According to the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) you are obliged to appoint an EU Authorised Representative medical devices (EC REP) if you want to trade your Medical Devices on the European market. EC REP meaning: “any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.” Thus, an EC REP acts as a liaison between a manufacturer outside of the EU and competent national authorities within the EU. The same function exists for the UK market; such a party is called a UK Responsible Person (UKRP). Hence, in the UK, they occasionally prefer to use the term “EU Responsible Person” rather than “EC Rep’ and therefore they require EU Responsible Person service.

What are the responsibilities of an EC REP?

The EC Representative takes on some of the manufacturer responsibilities, specified in the required mandate, including:

  • Registering the manufacturer’s devices in EUDAMED and devices from class I in Farmatec as well
  • Ensuring that the Declaration of Conformity (DoC) and other technical documentation have been drawn up
  • Verifying the conformity assessment procedure
  • Making the UK DoC and technical documentation available for the national surveillance authorities
  • Handling requests from said authorities; providing them with samples, requested documentation and information; and cooperating with them
  • Cooperating with the authorities to take preventive or corrective action with the purpose of eliminating or, if that is not possible, mitigating the risks posed by devices
  • Informing the manufacturer if there are any complaints and reports from healthcare professionals, patients or users about suspected incidents related to their medical device
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations, inform the national authorities and, if applicable, the relevant notified body, of the termination

EC REP labelling requirements

Lastly, it is important to know that the EC Representative should be mentioned by name and address on the packaging, user instructions, and product must have a EC rep labelling on your Medical Device as they function as your contact point for requests or concerns about your product. The EC REP label must contain the name and address of the EC REP next to the official EC REP logo or  EC REP symbol. If your Medical Device is both CE and UKCA marked, this is still mandatory. 

Who needs an EC Representative?

As already stated, EC REP services are mandatory by the MDR and IVDR for manufacturers based outside of the EU who want to sell their Medical Devices, all classes (including Active implantable medical devices and In Vitro Diagnostic Devices), on the EU market.

Who are the competent authorities in the Netherlands?

Manufacturers may only place a medical device or in vitro diagnostic device (IVD) in Europe if it complies with the statutory requirements. The Health and Youth Care inspectorate (IGJ) is responsible for monitoring, and supervising compliance. Additionally, IGJ also  oversees counterparts from the other European Member States. Dutch manufacturers or authorised representatives of non-EU manufacturers established in the Netherlands must register (notify) certain risk classes of medical devices and IVDs nationally.

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What is the procedure for AR Experts to become your EC REP?

After your request for an EC REP, we will send you a quotation on the requested services. Once you have accepted the quotation, we will start the documentation review together. In order to do this, one of our Compliance Experts will send you a link to a designated SharePoint environment to upload the technical documentation of the medical device(s) you want to place on the EU market.

Our team of experts will review the provided documentation and determine whether it is complete and meets the regulatory requirements for your medical device risk class.

Once it has been determined that the documentation meets the regulatory requirements, you will receive the EU REP agreement provided by our subsidiary AR Experts, which contains the mandate for Authorised Representation in the EU. After both parties have signed the agreement, AR Experts is officially your ECREP. 

AR Expert is already registered as an EC Rep in EUDAMED, the European Database on Medical Devices, to ensure your compliance with European medical device regulations. Manufacturers are required to register themselves and their medical devices in EUDAMED, and AR Expert can, if required, assist with this process. Once your registration is completed, AR Expert will confirm the registration in EUDAMED and will act as an official intermediary with regulatory authorities. Our experts are ready to draft a declaration (EC Rep certificate) to officially acknowledge our role as your EC Rep, if you find it necessary.

It is good to know that once the mandate has been signed, the tasks that it claims are officially assigned to the EC REP, should be carried out by the EC REP from that moment forward, whilst the manufacturer makes sure this is possible. I.e. the manufacturer compiles the required technical documentation and the EC REP ensures that it is accessible for the national authorities. An EC REP certificate is not mandatory, but can be provided if required.

Because the Technical Documentation is ‘live’ documentation, meaning it is susceptible to changes in regulations etc., it is important that the EU REPS monitors the documentation. Twice a year, it must be reviewed, and when changes are detected, a larger review must be performed. Because the ISO 13485 is an important part of the MDR, the EC REP is also qualified to request for internal audits. 

AR Experts also provide the following Authorised Representation services:


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Frequently asked questions

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Discover our Succes Stories

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Alfa Wassermann

Kurt Spiegel Vice President of Engineering
Certification Experts has been our partner for over 10 years and the relationship is outstanding. They’ve completed CE Marking, UKCA Marking, and act as our Authorized Representative. The face-to-face meetings are really important and save us a lot of time!

Choose us as your EC Rep!