UK Responsible Person (UKRP) Services

We provide comprehensive UK Responsible Person services to ensure your products meet all necessary regulatory requirements. As your designated UK Responsible Person, we act as the primary point of contact with regulatory authorities, handling product registrations, maintaining technical documentation, and ensuring compliance with safety and performance standards.

Our team of experts stays up-to-date with the latest regulatory changes, offering proactive support and guidance to prevent any compliance issues before they arise. With our services, you can confidently expand your market reach within the UK without the worry of navigating complex regulations on your own.

According to the UK MDR 2019, the UKRP is defined as “a person based in the United Kingdom who acts on behalf of a foreign manufacturer located outside the United Kingdom in relation to the manufacturer’s obligations under the regulations.

The UKRP serves as the UK’s equivalent to the EU authorized representative, with the role of the authorized representative no longer applicable in the United Kingdom.

It is essential that a medical device is placed on the I-JK market by either the manufacturer or a recognized UKRP.

To validate this arrangement, documentary evidence in the form of a mutually signed agreement (letter of designation) between the manufacturer and the UK Responsible Person is required. This agreement should include the names and addresses of both the overseas manufacturer and the UKRP, demonstrating that the UKRP is authorized by the manufacturer and that the devices comply with all relevant laws. The MHRA, on September 18, 2019, published new guidelines outlining the role and responsibilities of the UKRP in regulating medical devices after Brexit.

What Is a UK Responsible Person (UKRP) and Why Do You Need One?

Introduction

Expanding your business into the UK market is exciting, but let’s be real, compliance can be tricky. Regulations are strict, especially for cosmetics and medical devices. That’s where the UK Responsible Person (UKRP) comes into play. Without one, your products can’t legally be sold in the UK. And when it comes to finding the right partner, you don’t just need a service provider, you need an expert who knows the ropes inside out. That’s exactly what Cert3Global delivers.

With Cert3Global, you get more than just a name on paper. You get a trusted compliance partner who ensures your cosmetics and medical devices meet every UK regulation. That means no stress, no roadblocks, and no risk of product recalls.

 

What Is a UK Responsible Person (UKRP)?

A UK Responsible Person is a legal requirement for companies outside the UK that want to place cosmetics or medical devices on the UK market. After Brexit, this role became mandatory to ensure that non-UK manufacturers still have a representative based locally.

The UKRP acts as the official contact with regulatory authorities. They handle compliance documentation, safety reports, and communication with authorities like the MHRA. In short, they make sure your products are approved, safe, and market-ready.

When you choose Cert3Global, you’re choosing precision, professionalism, and peace of mind. Their team takes full responsibility so you can focus on growing your business.

 

Why You Need a UK Responsible Person

Without a UK Responsible Person, your products simply cannot be marketed in the UK. Here’s why having one, especially with Cert3Global, is non-negotiable:

  • Legal Requirement: UK law demands that cosmetics and medical devices imported from outside the UK must appoint a local responsible person.
  • Compliance Expertise: Regulations can be confusing. Cert3Global makes sure nothing slips through the cracks.
  • Authority Communication: If UK authorities need clarification, they deal directly with your responsible person. Cert3Global manages that for you.
  • Product Safety Assurance: Every product needs to meet strict safety standards before hitting the shelves.

 

UKRP Services You Can Rely On

When it comes to UKRP services, not all providers are created equal. With Cert3Global, you get a complete compliance package tailored to your products. Their services include:

  • Regulatory Compliance Checks – Reviewing and verifying your product information to ensure everything meets UK laws.
  • Product Registration – Handling the UK cosmetic portal and medical device registrations with accuracy.
  • Safety Documentation – Maintaining product information files, safety assessments, and technical documentation.
  • Communication with Regulators – Acting as the first point of contact with MHRA and other UK authorities.
  • Ongoing Support – Continuous monitoring and updates as regulations evolve.

 

UK Responsible Person for Cosmetics

If you manufacture or sell cosmetics, having a UK Responsible Person for cosmetics is a must. From skincare to makeup, every cosmetic product requires full safety documentation before it can be sold.

Cert3Global ensures your cosmetics are fully compliant by:

  • Preparing and maintaining Product Information Files (PIFs).
  • Submitting data to the UK Cosmetics Portal.
  • Ensuring ingredient compliance and labeling accuracy.
  • Handling any queries from UK regulators.

With Cert3Global as your compliance partner, you can launch your cosmetics with complete confidence.

 

UK Responsible Person for Medical Devices

Medical devices come with even stricter regulations. That’s why having a UK Responsible Person for medical devices is critical. Whether you’re dealing with diagnostic equipment, surgical tools, or health tech devices, the compliance requirements are tough.

Cert3Global takes charge of:

  • Registering medical devices with the MHRA.
  • Reviewing technical documentation for compliance.
  • Monitoring safety and vigilance reports.
  • Communicating with authorities on your behalf.

They don’t just manage paperwork; they protect your business by ensuring everything is in perfect order.

Additional Information on UKRP Services

Why CERT3GLOBAL For UKRP Services?

We offer Complete UKRP Services to ensure our clients can sell their Medical Devices in the UK Market in a seamless way.Our services are not limited to Clerical or Transactional Partnership,but we offer end to end solutions at every step of the process.

We have been in the market since 1999, our team comprises highly experienced Medical Device regulatory professionals National Representatives of seven countries who have the expertise to handle complicated devices and their regulatory aspects.

In addition to UKRP Services, we offer:

  • Support for UKCA Technical Documentation
  • Clinical Evaluation, Biological Evaluation,
  • Certification Body Coordination,
  • End to end solution for certification and compliance
  • ISO 13458 implementation and
  • MHRA Registration services.

For a smooth Business experience with us we offer multiple Payment Options, which gives you the flexibility to Pay according to your chosen Payment Method.

Team CERT-3 Global is a result driven,customer focused consultancy service. Having the experience of assisting numerous companies over the years gives us the ability to personalize and customize the service we offer to our clients. We Look forward to a fruitful association with you. You can send us a message or reach out to us directly on call. We are eager to help you.

Roles and Responsibilities of UKRP

  • Identification of appropriate GMDN Code at no additional charge.
  • Collaboration with associated laboratories for biocompatibility and safety testing in multiple countries.
  • Critical Investigation ,Evaluation and risk analysis of the device.
  • Assisting with correct medical device classification.
  • Ensuring the manufacturer follows the appropriate conformity assessment procedure.
  • Maintaining the latest technical documentation and records of the manufacturer.
  • Providing the MHRA (Medicines and Healthcare Products Regulatory Agency) with requested information and documentation.
  • Coordinating with the manufacturer in case of sample requests or device inquiries from the MHRA.
  • Cooperating with the MHRA to implement any corrective and preventive actions (CAPA) to mitigate potential risks.
  • Promptly informing the manufacturer about field incidents and complaints. Monitoring the manufacturer’s compliance with obligations under the MHRA Regulations.
  • Notifying the MHRA and terminating the UKRP relationship with the manufacturer, if necessary.
  • Opening a single registration account on behalf of the manufacturers we represent.
  • Supporting Post-Market Surveillance (PMS) activities.
  • MHRA Registration is Mandatory for Medical Devices and IVDs.

Required Details for MHRA Registration

To bring your medical device or (IVD) in-vitro diagnostic device to the UK market, Medicines and Healthcare Products Regulatory Agency ( MHRA) Registration is a non-negotiable requirement.

Here are the Information Essential for MHRA Registration Process :

Manufacturer (Facility) Information:

  • Legal manufacturer’s name, address, contact details (phone, email).
  • Description of activities conducted by the legal manufacturer.
  • Name, Email of the person responsible for communication with MHRA.
  • A mutually Signed agreement between legal manufacturer and the UK Responsible person

Medical Device Information:

  • Regulations applicable to the device.
  • Device’s risk classification.
  • Global Medical Device Nomenclature (GMDN) Code.
  • Basic Unique Device Identifier (UDI-DI).
  • Brand/trade name of the device.
  • Device model or versions.
  • Reference number of Instructions for Use (IFU), User
  • Manual, or Catalog.
  • Name and address of UK Approved Body or Notified
  • Body (excluding Class I devices).
  • Sterilization type (if applicable).
  • Details regarding Latex and phthalates.
  • MRI compatibility information for the device.

Who can be a UK Responsible Person?

Any third party entity/individual who is established in the UK and acts ‘on behalf of’ foreign manufacturers to register their (manufacturer’s) medical devices and IVD (In Vitro Diagnostic Devices) with MHRA(Medicines and Healthcare Products Regulatory Agency).

A UKRP must:

(i) have a registered place of business in UK
(ii) be able to address local grievances
(iii) be physically present in UK where technical documentation related to the product shall be maintained
(iv) be registered with MHRA
(v) ensure that conformity assessment of the device has been completed by the manufacturer.

A UKRP is essentially an Authorized Representative for manufacturers of Medical Devices and will generally fulfill the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR)

What does a UK Responsible Person do?

A UKRP ensures your cosmetics or medical devices comply with UK regulations and communicates with UK authorities on your behalf.

Do all cosmetics need a UK Responsible Person?

Yes, every cosmetic product sold in the UK must have a designated UKRP.

Why do medical devices require a UK Responsible Person?

Medical devices need strict oversight to ensure safety, quality, and regulatory compliance before being sold in the UK.

Can I appoint anyone as my UK Responsible Person?

No, the role requires regulatory expertise and compliance knowledge. That’s why partnering with experts like Cert3Global is essential.

How does Cert3Global support with UKRP services?

They handle registrations, compliance checks, safety documentation, and communication with UK regulators for both cosmetics and medical devices.

What happens if I don’t appoint a UK Responsible Person?

Without a UKRP, your products cannot legally enter the UK market, which could lead to financial losses and reputation damage.

Conclusion

Breaking into the UK market should be an exciting opportunity, not a compliance headache. That’s why appointing a UK Responsible Person is crucial. And when it comes to reliability, expertise, and complete regulatory support, Cert3Global is the partner you need.

From cosmetics to medical devices, they take care of every detail, ensuring your products meet all UK requirements. Don’t leave compliance to chance. Trust Cert3Global to be your official UKRP and secure your path to success.