UK Responsible Person (UKRP) Services for Medical Devices & Cosmetics
Trusted UK regulatory support for overseas manufacturers, including MHRA registration, UK MDR 2002 compliance, and UKCA guidance.
Looking for trusted UK Responsible Person (UKRP) services for medical devices and cosmetics? Accurate Assessments supports overseas manufacturers with MHRA registration, UK MDR 2002 compliance, UKCA guidance, and regulatory consultancy services for the UK market.
Comprehensive UKRP & Regulatory Compliance Services
UKRP Services
UK Responsible Person services for overseas medical device manufacturers entering the UK market, including MHRA registration and UKCA compliance.
UK MDR Compliance
Expert UK MDR 2002 compliance support, technical documentation review, and regulatory strategy services.
Cosmetics Compliance
Regulatory support for cosmetics companies, including Responsible Person services and product compliance.
Technical File Support
Technical documentation support for medical devices including labelling review and compliance checks.
Claims & Compliance Review
Review of cosmetic and medical device claims to support UK and EU compliance requirements.
Product Registration
Support with MHRA registration, UKCA guidance, and market access for medical devices and cosmetics.
Medical Device UKRP Services
MHRA registration, technical documentation review, UKCA guidance, and post-market compliance support.
Cosmetics RP
Support with cosmetic product compliance, product notification, labelling review, and UK market access.
Regulatory Support
Practical compliance support, regulatory reviews, audits, and ongoing guidance for manufacturers.
How Our UKRP Process Works
Initial Consultation
Discuss your products, compliance requirements, and UK market entry needs.
Documentation Review
We review technical files, labelling, and regulatory documentation.
MHRA Registration
We handle UKRP appointment and MHRA registration processes.
Ongoing Compliance Support
Continuous support for audits, updates, and ongoing compliance.
Who Needs UKRP Services?
UK regulations require overseas manufacturers and brands selling medical devices or cosmetics in the UK to appoint a UK Responsible Person (UKRP).
Medical Device Manufacturers
Overseas manufacturers placing medical devices on the UK market.
Cosmetic Brands
Brands selling cosmetic products in Great Britain.
Amazon & Ecommerce Sellers
Online sellers needing UK compliance before listing products.
Importers & Distributors
UK supply chain partners placing products on the market.
Private Label Brands
Businesses selling products under their own brand name.
Overseas Manufacturers
Non-UK companies requiring a UK Responsible Person.
Wellness & Beauty Brands
Health, beauty, and personal care brands entering the UK.
Regulatory Partners
Consultants and businesses needing UKRP support for clients.
Frequently Asked Questions
What is a UK Responsible Person and who needs one?
Products such as medical devices, in vitro diagnostic devices (IVDs), cosmetics, and certain regulated consumer products often require an EU Authorised Representative or UK Responsible Person before being placed on the market.
What product categories require an EU or UK Authorised Representative?
Typical categories include:
- Electronics and electrical equipment
- Toys and children’s products
- Cosmetics
- Medical devices & IVDs
- Machinery & industrial products
- PPE and safety equipment
- Radios, IoT, wireless products
- Food-contact items
- Household and consumer goods
- Chemical products and aerosols
If the regulation requires a local representative, you must appoint one before selling.
What are the responsibilities of an EU/UK Authorised Representative?
Your EU Authorised Representative or UK Responsible Person will:
- Hold and maintain your technical documentation
- Verify regulatory compliance before placing products on the market
- Act as the contact point for authorities
- Assist with inspections, audits, and testing requests
- Handle safety incidents, recalls, and SCMS/SBG notifications
- Ensure your product has correct labeling, CE/UKCA marking, and traceability
- Maintain documents for 10–15 years, depending on regulation
Which EU laws and directives require an Authorised Representative?
This varies by product category but may include:
- GPSR (EU 2023/988)
- Toy Safety Directive (2009/48/EC)
- Medical Device Regulation (MDR 2017/745)
- IVDR (2017/746)
- EMC Directive (2014/30/EU)
- Low Voltage Directive (2014/35/EU)
- Radio Equipment Directive (RED 2014/53/EU)
- PPE Regulation (EU 2016/425)
- Machinery Regulation (EU 2023/1230)
- Cosmetics Regulation (EC 1223/2009)
- RoHS (2011/65/EU)
- REACH (EC 1907/2006)
- Food Contact Materials Regulation
Do I need an EU Authorised Representative even if I sell only through Amazon or Shopify?
Yes. Selling through Amazon, Shopify, eBay, or your own website is still considered placing products on the EU or UK market. Most online marketplaces now require overseas manufacturers to provide valid EU/UK Authorised Representative or UK Responsible Person details before products can be listed or sold.
What documents must I provide to my AR/RP?
The required documents depend on your product type and applicable regulations. In most cases, manufacturers will need to provide:
- Technical file
- Declaration of Conformity
- Test reports (EN/ISO standards)
- Risk assessment
- Manufacturing details
- Label artwork with AR/RP address
- Safety data sheets (chemicals/aerosols)
- PIF/CPSR (for cosmetics)
- Device documentation (for medical devices)
Additional documents may be required depending on the product category and market requirements.
What address will appear on my product labels?
Your product labels will display the official address of your EU Authorised Representative or UK Responsible Person, as required by applicable regulations. This address must appear on the product, packaging, or accompanying documentation so authorities and customers can identify the responsible regulatory contact within the EU or UK market.
Does Accurate Assesments review my technical file?
Yes. Your documentation is reviewed for completeness, clarity, and regulatory compliance. Any missing information, labelling issues, or non-conformities are identified, and guidance is provided to help ensure your technical documentation meets applicable UK and EU regulatory requirements.
What happens if a Market Surveillance Authority contacts ?
Our compliance team:
You will be kept informed throughout the process. If a Market Surveillance Authority contacts you regarding your products, your EU Authorised Representative or UK Responsible Person will help manage the regulatory process and support communication with the relevant authorities.
- Responds directly to authorities
- Provides technical documentation
- Handles safety checks
- Guides you through corrective actions, if needed
- Supports recalls or incident notifications
Can we support foreign companies with no EU/UK presence at all?
Yes. Our EU Authorised Representative and UK Responsible Person services are specifically designed for overseas manufacturers and brands without a physical presence in the EU or UK.
We support companies from the US, China, Switzerland, UAE, Australia, India, and many other countries by helping them meet EU and UK regulatory requirements before placing products on the market.