EC REP
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
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.
Choose us as your EC Rep!
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:
- EU Authotised Representation
- UK Authorised Reresentation
- UK Responsible Person (UKRP) for Medical Devices
Check out our EC Rep services
Click on the service blocks to see our EC Rep offerings
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 a European Authorised Representative (EC REP) if you want to trade your Medical Device(s) on the European market. AR Experts (part of Certification Experts) can act as an EC REP on behalf of your organisation.
- Aid in CE marking conformity assessment procedure
- Authorised representative agreement/mandate
- Technical file and Documentation review
- Acting as a contact person with the competent authorities
- Provide legal advice
- Registering the manufacturer’s devices in EUDAMED
PRRC
Certification Experts can offer to act as a Person Responsible for Regulatory Compliance (PRRC) in the context of medical devices. . The PRRC is a crucial role mandated by the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure compliance with regulatory requirements for medical devices and in vitro diagnostics. Certification Experts can also act as the Deputy PRRC. A Deputy PRRC, or Deputy Person Responsible for Regulatory Compliance, is an individual appointed by a medical device or in vitro diagnostic device manufacturer to assist the PRRC in fulfilling their duties related to regulatory compliance.
- PRRC
- Deputy PRRC
- Guiding PRRC and/or Deputy PRRC
Mandate for Authorised Representation
AR Experts (part of Certification Experts) will set up the required mandate/agreement, herein it is determined which responsibilities/tasks of the manufacturer are mandated to the EUAR, UKAR, EC Rep and/or UKRP. This is based on the applicable directives and regulations.
- EU Authorised Representative agreement (mandate)
- UK Authorised Representative agreement (mandate)
- EC Rep agreement (mandate for medical devices)
- UKRP agreement (mandate for medical devices)
Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) 2017/745, effective since May 26, 2021, imposes stricter requirements on medical device manufacturers. Certification Experts, with over 25 years of experience, can assist in MDR compliance.
- Legal risk classification of medical devices
- GAP Analysis MDR + MDD to MDR
- GAP Analysis QMS
- Templates Technical File and QMS
- Guidance, implementing and assessing QMS
- Guidance and/or Review Technical File
- EC Rep / UKRP
- PRRC
- Risk Management
- Consult with Expert
Quality Management System
Quality Management System services help businesses establish and maintain effective quality management processes. This involves implementing procedures, training, auditing, and continuous improvement to meet customer expectations and industry standards. Our team at CE Medical (part of Certification Experts) can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. Additionally, we can provide an appropriate QMS based on your situation and wishes.
- ISO 13485
- ISO 9001
- Article 10 Quality Management System MDR
All the answers you might need!
The EC Rep logo, or EC Representative logo, is a mandatory symbol used to indicate that a company outside the European Union (EU) has appointed an Authorised Representative (EC Rep) to fulfill regulatory responsibilities within the EU market. This logo is often included in product documentation, labels, and packaging to signify that the appointed representative ensures compliance with EU regulations on behalf of the non-EU manufacturer. This visual indication is crucial for demonstrating conformity with the requirements for medical devices in the European market.
A European Responsible Person is responsible for all of the tasks that they and the manufacturer agree on, which are established in an official mandate. These include but are not limited:
- Registering the manufacturer’s devices in EUDAMED.
- Ensuring that the EU Declaration of Conformity (DoC) and other technical documentation are prepared.
- Verifying the conformity assessment procedure.
- Providing the DoC and technical documentation to national supervisory authorities.
- Handling requests from these authorities, providing samples, required documentation, and information, and collaborating with them.
- Collaborating with authorities to take preventive or corrective action, aiming to eliminate or, when not possible, minimize the risks of the Medical Devices.
- Informing the manufacturer in case of complaints and reports from healthcare professionals, patients, or users regarding suspected incidents with their medical device.
- Terminating the legal relationship with the manufacturer if they fail to comply with the requirements stated in the Regulations, informing the authorities about this, and, if applicable, the Notified Body (NoBo).
EC Rep meaning: “European Authorised Representative.” An EC Rep is an individual or entity appointed by a manufacturer located outside the European Union (EU) to act as their representative within the European Economic Area (EEA). It is a liaison between a manufacturer outside of the EU and competent national authorities within the EU. The EC Rep is responsible for ensuring that the manufacturer’s medical devices comply with European regulations and standards. These 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.
A Responsible Person is a legal party based within the EU or UK that acts as a liaison between a manufacturer of Medical Devices outside of the EU or UK and competent national authorities within the EU or UK. A Responsible Person EU is officially called the EC REP and in the UK the UK Responsible Person (UKRP). The UK and EU responsible person requirements are to take over some of the manufacturer responsibilities, and to make sure that the devices being sold on the EU or UK market comply with the relevant national compliance legislations. This way, safe and legal trade of your devices is guaranteed.
An EC REP certificate can be drafted, by the EC REP, confirming their role as the European Authorised Representative (EC REP) for medical devices. It’s important to note that such certificate is typically voluntary and not a formal requirement under European Medical Device Regulation (MDR). While it can provide additional clarity and documentation regarding the relationship between the manufacturer and the EC REP, it doesn’t carry the same regulatory weight as other mandatory documentation and responsibilities outlined by the regulations.
The European Authorized Representative (EC Rep) for medical devices can be an individual or an entity. For individuals, they must have the necessary qualifications, be located within the EU or EEA, and be proficient in required languages. Entities serving as EC Reps must be established within the EU or EEA and possess the expertise and resources to fulfill responsibilities. The EC Rep is responsible for ensuring compliance with EU regulations, acts as a point of contact with regulatory authorities, and handles tasks such as documentation and cooperation with competent authorities. Manufacturers should carefully select an EC Rep with expertise in the specific category of medical devices to ensure effective representation and compliance.
If you are looking for a suitable EC Rep to assist you in gaining access to the UK market quickly and efficiently, our team of experts with over 25 years of experience is pleased to offer our services.
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