Your Fast-Track to the European Market
Official EU Authorised Representative for Medical and Electronic Products
Enter Europe with confidence, within 24 hours.
Non-EU manufacturers of medical devices and electronic equipment are legally required to appoint an Authorised Representative (AR). At Certification Experts, we make this process fast, simple, and reliable.
- One trusted partner for EU, UK, and Switzerland.
- 24-hour AR setup.
- Expertise in both Medical and Electronics sectors.
A quick overview of this page
What You Need to Start
To appoint us as your EU Authorised Representative, your product must comply with CE marking requirements and have a complete technical file, a Declaration of Conformity, and proper labelling. Once this is in place, we can act on your behalf immediately.
⚠️ Important: Without an EU AR, non-EU manufacturers cannot legally place their medical or electronic products on the European market.
What We Offer
As your compliance partner, we don’t just sign paperwork. We ensure your products meet European requirements and represent you with local authorities. Our services include:
- Official EU Authorised Representative (EC-REP)
- Optional UK (UKRP) and Switzerland (CH-REP) coverage
- Registration with relevant authorities (EUDAMED, MHRA, Swissmedic)
- Compliance check of documentation and labelling
- Support with CE marking and technical files (if needed)
- Ongoing communication with authorities on your behalf
Sectors We Serve
Medical Devices – We help MedTech innovators comply with MDR requirements and accelerate their route to market.
Electronic Equipment – From consumer products to complex industrial systems, we ensure compliance with EU directives and CE marking.
Why Choose Certification Experts
- Speed: 24-hour AR activation if documentation is complete.
- Coverage: One single partner for EU, UK, and Switzerland.
- Expertise: In-depth knowledge of medical devices and electronics.
- Support: Direct communication in English and Chinese, with offices in Europe and Asia.
Start Today
Ready to bring your product into Europe? Submit your request today, if your documentation is complete, you’ll be officially represented within 24 hours.
Certification Experts – Your Compliance Partner in the EU, UK & Switzerland
Start your AR process now
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)
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.
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