UKCA Experts

European Authorised Representative and Product Compliance Services

UKCA Experts is part of Certification Experts and, in addition to providing UK AR and UKRP services for European businesses, also offers specific services tailored to UK businesses. Based in the UK, UKCA Experts Ltd. collaborates with its European parent company to provide European Authorised Representative and Product Compliance Services.

UKCA Experts

UKCA Experts operates as an integral component of Certification Experts, extending its services beyond UK AR and UKRP offerings to cater specifically to the needs of UK businesses. Situated in the UK, UKCA Experts works in tandem with its European parent company, facilitating the provision of European Authorised Representative and Product Compliance Services.

Challenges for UK businesses

Post-Brexit, UK businesses encountered formidable challenges exporting to Europe. Regulatory disparities demanded recalibration, with the need for both UKCA and CE markings. Authorised Representation complexities and increased customs checks led to supply chain disruptions. While stringent testing and certification processes added time and financial burdens. Data transfer concerns and market access restrictions further complicated the landscape. Navigating this intricate environment necessitated staying informed, seeking professional guidance, and ensuring compliance with both UK and EU standards.

How UKCA experts can help

In the post-Brexit trade landscape, UKCA Experts act as trusted business partners for UK businesses. Their expertise in regulatory matters facilitates a smooth transition, ensuring compliance with both UK and EU standards. We offer crucial assistance in the appointment of Authorised Representatives, helping businesses meet EU regulations and access European markets. As market access becomes more complex, UKCA Experts collaborate with businesses to devise strategies that keep doors open to the European market.

Who We Serve

UKCA Experts

Trust UKCA Experts to be your UK Business Partner

Post-Brexit Trade: Why UK Exporters Need European Authorised Representatives

As of January 1st 2021, the United Kingdom left the European Union, and new trade and cooperation agreements came into effect. Following the United Kingdom’s departure, various EU trading conventions were withdrawn and the UK became regarded as a third-world country to the European Union market. This means that UK exporters to the EU now require a European based entity who represents them in the European Union market. This can be either an importer, or a dedicated European Authorised Representative (EAR) company.

Appointing a dedicated EAR company – such as AR Experts, a company of which UKCA Experts is a subsidiary, is the most desirable and recommended option in order to facilitate the exportation of various products to the European Union (EU) for a variety of reasons.

Reasons to appoint UKCA Experts as your dedicated EAR company:

The European Union has specific Regulations and Directives that govern the safety and performance of various products. To ensure compliance with these regulations, a UK exporter needs to have a representative within the European Union who can liaise with the relevant authorities and ensure that their products meet European standards.

UKCA Experts serves as a point of contact between a UK company and its European competent authorities, such as national market surveillance authorities. In the event of any regulatory inquiries, audits, or requests for information, having UKCA Experts as your Authorised Representative in the EU, can facilitate communication and ensure a smoother process.

Appointing UKCA Experts as your EAR helps a UK exporter maintain a presence in the European Union and navigate the regulatory landscape effectively. UKCA Experts assumes responsibility for keeping the required technical documentation, including the Declaration of Conformity and product information, readily available for inspection by national, federal authorities within the European Union.

By appointing UKCA Experts as an EAR, you can transfer certain responsibilities to the us as your Authorised Representative. This can be particularly helpful in managing legal and regulatory requirements associated with the European Union market.

Appointing UKCA Experts will enhance your credibility in the European market, promoting expertise and growth. It signals to customers, distributors, and regulatory authorities that a UK exporter is committed to comply with European regulations and standards.

Is an Authorised Representative mandatory for UK Exporters?

While appointing an EAR is not mandatory for all products, it is often considered a practical and strategic choice when a UK exporter looks for continuation or expansion in the European Union market. It helps streamline regulatory processes and ensures that products meet the necessary standards for sale within the European Union. Careful review of a company’s product type and specific situation should be given. UKCA Experts has experts on hand that can provide advice at any stage.

For products that fall within the General Product Safety Directive (GPSD) an EU Authorised Representative is not mandatory, but highly recommended. E-commerce platforms are likely servicesto demand from you to appoint an EU AR, as the new GPSD states that they are responsible for potential hazards as well, and appointing an authorised representative would relieve them from these obligations. 

Choose us as your UK Business Partner

What is the procedure for UKCA Experts to become your EU Representative?

When you’ve decided to utilize our EU Authorised Representative services, we kick off the process by gathering the necessary technical documentation, a crucial step to initiate the technical file review. This enables us to potentially furnish you with the Authorised Representative agreement within just 24 hours. Upon signing the AR agreement, you’ll promptly receive an AR certificate, formally designating us as your European Authorised Representative.

It’s important to note that once the mandate is signed, the designated tasks are officially delegated to the European Authorised Representative, who will handle them going forward. This relieves the manufacturer of those responsibilities, as they are now outsourced to us.

AR Experts also provide the following Authorised Representation services:

  • EU Authorised Representation
  • EC Rep for Medical Devices

A few product groups are not within our EU Authorised Representative services, among which: food, medicines, cosmetics, and chemicals. These products are subjected to different rules, which are not explained here. 

Other services UKCA Experts can provide to UK businesses

For UK businesses, UKCA Experts offers more than just the Authorised Representation in Europe, the EU Authorised Representative, and the EC Rep. We also provide services for the entire EU compliance process. This includes the complete CE marking process for various products, compiling Technical Files, conducting risk assessments, and issuing declarations. Additionally, we have a dedicated Medical Devices team that can support companies within the medical devices supply chain with tasks such as MDR compliance, QMS ISO 13485, Technical File Templates, QMS documentation, Corrective and Preventive Actions (CAPAs), and other MDR and QMS-related services. Our team is committed to ensuring that your products meet all regulatory requirements for market access in the EU.

Portfolio

Check out the services UKCA Experts offers:

Click on the service blocks below to see part of our EU Services:

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

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

CE Marking

The CE mark serves as proof that a product complies with European product regulations. It’s a mandatory requirement for manufacturers whose products fall under applicable CE directives and regulations before they can enter the European market. Additionally, other parties like importers, distributors, and authorized representatives have their roles in ensuring that products bear the CE mark. Obtaining CE marking can be a complex and time-consuming endeavor. It involves understanding regulatory requirements, accessing the necessary testing facilities, and managing time effectively. Our team of CE mark consultants is here to support you throughout this process. We’ll guide you, conduct the required testing, and simplify the path to obtaining CE marking for your products. As your dedicated compliance partner, we aim to streamline this often intricate procedure.

  • Conformity Assessement procedure
  • Technical File
  • Risk Assessment
  • Inspection/Safety Assessment
  • Testing
  • Declaration of Conformity
  • Authorised Representation

Training CE marking process

Certification Experts offers training programs that will prepare you for the CE marking process of your  product.  

  • CE marking
  • Safexpert software

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
Frequently asked questions

All the answers you might need!

A CE mark authorized representative for UK businesses is an entity or individual appointed by the UK manufacturer, required by a company who is based outside the European Union (EU), to act as their legal representative within the EU market. This representative plays a crucial role in facilitating market access and ensuring compliance with EU regulations for UK businesses seeking to sell their products within the European Economic Area (EEA).

The EU Authorised Representative service entails the appointment of a designated entity or individual by a manufacturer based outside the European Union (EU), such as UK businesses, to serve as their legal representative within the EU. This service is particularly vital for UK businesses seeking to introduce their products into the EU market, as it streamlines market access and guarantees adherence to EU regulations. By providing a direct link between the manufacturer and EU regulatory authorities, this representation ensures that UK businesses can navigate compliance requirements effectively. Ultimately, it empowers UK businesses to lawfully sell and distribute their products throughout the European Economic Area (EEA), fostering seamless trade relations and market expansion opportunities.

In the European Union, appointed representative services for UK businesses are typically provided by specialized regulatory consulting firms or companies that have expertise in navigating EU regulations and compliance requirements. These appointed representatives act as intermediaries between the UK businesses and EU regulatory authorities, ensuring that the businesses meet all necessary regulatory obligations within the EU market.

Testimonials

Discover our Succes Stories

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!

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.

Choose us as your EU Authorised Representative!