Your Authorised Representative for Smooth Access to the EU Market

Fast-track your medical or technology product into Europe, with one trusted point of contact.

Are you a Canadian manufacturer ready to sell in Europe? EU regulations require non-European companies to appoint an Authorised Representative (AR). At Certification Experts, we make this process fast, reliable, and stress-free.

  • Expertise in Medical Devices and Technology sectors
  • 24-hour AR activation if documentation is complete
  • Coverage for EU, UK, and Switzerland
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Summary

A quick overview of this page

Expanding from Canada to Europe

Crossing into a new market is more than logistics, it’s about compliance. With us as your AR, you avoid regulatory pitfalls and secure a smooth path to Europe.

Fast-Track Market Entry

If your documentation is in order, we can represent you officially within 24 hours. That means no delays and no missed opportunities in one of the world’s largest markets.

A Trusted Partner for Canadian Manufacturers

Whether you’re based in Ontario, Quebec, or beyond, Canadian innovators already rely on Certification Experts to bring their MedTech and technology products to Europe.

What You Need to Start

To appoint us as your AR, you need to have CE marking in place, including a technical file, Declaration of Conformity, and compliant labelling. Once this is ready, we can legally represent you in the EU within one business day.

⚠️ Reminder: Without an EU AR, non-EU manufacturers cannot legally place medical or electronic products on the European market.

What We Offer

As your Authorised Representative, we act as your official legal presence in Europe. Our services include:

  • Official EU Authorised Representative (EC-REP)
  • Optional UK (UKRP) and Switzerland (CH-REP) coverage
  • Registration with European authorities (EUDAMED, MHRA, Swissmedic)
  • Compliance check of documentation and product labelling
  • Optional CE Marking guidance and support
  • Continuous communication with EU authorities on your behalf

Sectors We Serve

Medical Devices – Helping Canadian MedTech companies comply with MDR requirements and reach European patients faster.
Technology & Electronics – From advanced technology products to industrial electronics, we ensure compliance with EU directives and CE marking.


Why Canadian Companies Choose Certification Experts

  • Speed: AR service active in 24 hours if documentation is complete.
  • Coverage: One partner for EU, UK, and Switzerland.
  • Expertise: Strong experience with medical, technology, and electronic sectors.
  • Proximity: We work closely with Canadian manufacturers, especially in Ontario and Quebec, where demand for CE-marked products is growing.


Get Started Now

Your products deserve access to the European market, we make that possible. Let’s get you compliant, fast.

Start your AR process now

Contact us
+31 (0)85 007 3210
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ISO27001 & ISO9001 certified – Trusted by 300+ Clients

Services

AR Experts offers the following services

Below you can see what role our experts play in ensuring that your product can safely and legally be sold on the EU market.

Authorised Representation

AR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU and/or UK market comply with the applicable product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider. 
We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more.  

  • EU Authorised Representative
  • UK Authorised Representative
  • EC Rep (Medical Devices)
  • UK Repsonsible Person (UKRP)
  • Responsible Person (RP) GDP
  • Person Responsible for Regulatory Compliance (PRRC)

EU Authorised Representation

AR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU market comply with the European product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider. 
We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more. 

  • 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

UK Authorised Representation

UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations we operate in various sectors such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more. 

  • Aid in UKCA marking conformity assessment procedure
  • UKRP agreement/mandate
  • Technical file and documentation review
  • Acting as a contact person with the competent authorities
  • Provide regulatory advice

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 Dossier and Documentation review
  • Acting as a contact person with the competent authorities
  • Provide regulatory advice

UK Responsible Person (UKRP)

As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom as their UKRP.

  • UKRP agreement/mandate
  • Technical Dossier and documentation review
  • Providing regulatory advice
  • Registration of your devices at the MHRA

AR services private labeller

You can only appoint an EUAR/UKRP if you are a manufacturer. If you are a reseller, it is necessary to become a private labeller in order to appoint an EUAR or a UKRP. When placing a product on the market under a private label, you will be considered as the legal manufacturer. This means that you will bear all the obligations of a manufacturer and can appoint AR Experts (part of Certification Experts) as your EUAR/UKRP.  

  • Setting up a private label agreement with the Original Equipment Manufacturer (OEM)
  • Aid in CE/UKCA marking conformity assessment procedure
  • Authorised representative agreement/mandate
  • Technical file and documentation review
  • Medical device registration
  • Acting as a contact person with the competent authorities
  • Provide regulatory advice

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)​
Frequently asked questions

All the answers you might need!

European Authorised representative (AR) services are for manufacturers based outside of the EU who want to sell their product on the EU market. It should be noted that the requirement for an EU Authorized Representative (AR) is mandatory only for manufacturers of Medical Devices (EC Rep). Manufacturers dealing with other product groups in the EU market are not obligated to have an EU AR but have the option to appoint one if they choose to do so. Authorised Representation also exists for the UK market. This would be a UK Authorised Representative or UK Responsible Person (UKRP). Right now, the requirements for the UK market and representation are essentially the same.

An AR is a legal party based within the European Union or the UK that acts as a liaison between a manufacturer outside of the EU/UK and competent national authorities within the EU/UK. The AR makes sure that the products being sold on the EU/UK market comply with the relevant national compliance legislations. This way, safe and legal trade of your products is guaranteed. 

A European Authorized Representative 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: reviewing the CE marking, ensuring the availability of technical files for market surveillance authorities, and cooperating with them. For more information on what Authorized Representative services entail, click here.

There is no European Authorised Representative list; a manufacturer is free to assign any Authorised Representative of choice. If you are looking for a suitable AR that will help you gain access to the EU/UK market fast and efficiently, our experts with 25+ years of experience are happy to help. A manufacturer could also choose to appoint an importer or a Fulfilment Service Provider as this is also recognised as a European Economic Operator by the EU Market Surveillance Regulation (MSR). This is not advisable due to potential conflicts of interest and differences in their roles. Combining specific roles may lead to issues such as conflicts, lack of expertise, and potential legal implications.

An EC Authorised Representative helps non-European manufacturers to comply with EC regulations. They act as a bridge between these manufacturers and EU regulatory authorities, ensuring proper documentation, product compliance, and consumer safety. The EC Rep also coordinates recalls and corrective actions, and assists with vigilance cases. Staying up-to-date with EU regulations is a key part of their role.

Testimonials

What our clients are saying about us

Gallery Play Media

Ruben Kieftenbelt CTO
Our experience with Certification Experts was pleasant and valuable. The test results during the certification project were comprehensive and detailed and they swiftly offered solutions when there were obstacles.

Nikon

Joachim Hofmann GM Service & Support
Collaboration with the Certification team has been very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. We look forward to collaborating for our future endeavors!

Physee

Wai-Man Tang Quality Assurance Manager
We have a wonderful experience working with Certification Experts. We are a scale-up company that specialises in doing product developments under a very tight timeline, and the team expertly adjusts to our needs and guides us step by step!

Dot Robot

Edward Belderbos Technical Director
It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us how to proceed in order to be in compliance with European directives.

Noffz

Markus Solbach Director Sales & Marketing
Certification Experts offers great service with high flexibility and a fast response time. Their technical understanding and detailed feedback to our complex test solution in a short timeframe is impressive!

Government of Canada

Melanie Ter Meulen Trade Comissioner
Certification Experts is a valuable partner to us. The collaboration runs smooth and if Dutch companies require specific technical information, Certification Experts is able to provide this.

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.

Fette Compacting Belgium BV

Kris Schoeters Technical Sales Support & Project Management
The team at Certification Experts ensured a new way forward for the Fette Compacting team, wherein they ensured a higher level of safety for our operators.

Nutek

Marc Schaerlaeckens Managing Director
Certification Experts made sure to consider every possible phase of CE marking processes, ranging from how to make the right design choices to composing a technical file.

Oceanteam

Lars van ‘t Kruijs Managing Director
The team at Certification Experts provide excellent cooperation! They provide detailed explanations and think-along solutions.

Confocal.nl

Peter Drent CEO
Personally, I am very satisfied with the service and quality of the work of Certification Experts. I certainly intend to work with them for future projects!

Adtrackmedia

Paul East CTO
Certification Experts has been helpful, knowledgeable and prompt – even during difficult circumstances surrounding the pandemic. We look forward to working with Certification Experts on future projects.

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!

Bondtech Corporation

Elsa Brown President
For more than 15 years, Bondtech has had the pleasure of being partnered with Certification Experts for CE marking for Europe and the UKCA for the UK. Their professionalism, rapid responses, and attention to detail impressed us. Their tailored guidance and meticulous review of our specifications ensured compliance with CE directives. In addition to conducting the conformity assessment process for us, they also act as our Authorised Representative. We recommend Certification Experts for their expertise and personalized service, which not only secured our certifications but also provided invaluable support.

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Safexpert Review 1

For us Safexpert is the ideal tool for risk assessments and CE-documentations. The structuring of plant-projects gives us the possibility also to handle big/complex projects in a clear and structured way. But also for Risk assessments for machinery outside Europe Safexpert is a very helpful tool.

Safexpert Review 2

A good software for safety analysis and risk assessment.

Safexpert Review 3

A straight one, easy to use program with many options.

Safexpert Review 4

A versatile program for the entire CE process.

Safexpert Review 5

Useful software to get CE marking. It saves a lot of time.

Safexpert Review 6

A program which helps you to get into the labyrinth of CE norms.

Safexpert Review 7

Seems to be a very strong and structured product to do Risk Assessment and CE marking.

Safexpert Review 8

A powerful and helpful program.

Aria Technologies

Omar Ahmed Senior QA/QC Engineer
Certification Experts facilitated us to obtain the CE mark for our Cartesian Robot, enabling us to access the European market. Their clear communication and personalized approach made our collaboration a pleasant experience.

Full-service product compliance

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+31 (0)85 007 3210
info@certification-experts.com
ISO 9001 Certified
ISO 27001 Certified
ISO27001 & ISO9001 certified – Trusted by 300+ Clients