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
Challenges an EC REP can solve for you
How AR Experts can help
Who We Serve
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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