Taylored Solutions for UK Responsible Person and UK Regulations

Do You Need Support With

  • Complex and Revolving Regulations

  • Documentation and Technical Files

  • Product Labeling and Claims

  • Market Access Challenges

  • Quality Control and Product Safety

  • Non-Compliance Resolution

  • Cosmetics, Medical Devices & Food Supplements Regulation

Taylored Consultancy provides expert guidance and tailored regulatory solutions through our certified legal team, working closely with your company to manage documentation and ensure full compliance, making it easy to meet all legal requirements for the medical devices, cosmetics and food supplements

Need Expert Advice?

Let’s Make Compliance Simple

Committed to Compliance Excellence

Food Supplements

Cosmetics

Medical Devices

Why Do I Need A UK Responsible Person? (UKRP)

Since Brexit, non-UK manufacturers must appoint a UK Responsible Person (UKRP) to ensure regulatory compliance and manage device registrations in Great Britain. Taylored Consultancy serves as your UKRP, acting as your UK presence, handling technical documentation, post-market surveillance, and liaising with UK authorities. We help reduce regulatory risks, guide you through compliance, and address potential issues before they arise.

● Northern Ireland special provisions

To enter the Northern Ireland market, you must have an Authorized Representative based in the EU or Northern Ireland.

What Are The UKRP Responsibilities?

Non-UK manufacturers need a UKRP post-Brexit. Taylored Consultancy handles compliance, documentation, and communication for smooth market access.

Regulatory Requirements:

Appointing a UK Responsible Person is mandatory for importing medical devices and cosmetics into the UK. Non-UK manufacturers need a UK-based entity to handle product registrations with the MHRA. For cosmetics, the Responsible Person ensures safety and compliance, regardless of where the product is made. Food Supplement manufacturers require a UK Food Business Operator (FBO) to be able to sell and market their products in the UK. FBO registrations can only be made for UK based entities with their local council.

Product Registration:

Our role is to register your products with the appropriate regulatory authorities. Once the product(s) are approved, we'll let you know so you can start or continue selling.

Compliance Check:

We'll provide you with a 'UKRP Checklist' to request the necessary documents for review, ensuring your medical devices, food supplements and cosmetics comply with UK regulations. If any gaps are identified, we can assist in creating and/or confirming compliance.

Ongoing Compliance:

After your product enters the market, we ensure ongoing compliance by staying informed on legal and regulatory changes, responding to authority requests, providing necessary documentation, and demonstrating conformity on your behalf.

Ready to Simplify Compliance?

Let us handle the complexities of UK and EU regulations, so you can focus on growing your business.

What Our Clients Say

I am writing to wholeheartedly recommend Bethany, whose collaboration has not only been immensely valuable but truly transformative in our recent project. Bethany stands out as a beacon of professionalism, demonstrating a level of dedication and expertise that is rare and highly commendable. Her dynamic approach to challenges is both refreshing and effective, allowing our team to navigate complexities with confidence. Bethany possesses a unique ability to anticipate the needs of a project, taking informed, proactive steps that ensure success. This foresight, combined with her willingness to take initiative in key decision-making processes, has significantly contributed to our achievements. I highly recommend Bethany, without hesitation!

Sven, Managing Director

Quotation Marks

Taylored Consultancy were clear with direction, great at communicating, and easy to get in contact with.

Jan, Director

Quotation Marks

Working with Taylored Consultancy has brought an additional layer of expertise to our business. Collaborating with Bethany has allowed us to remain compliant, whilst offering practical solutions that help us to clearly and effectively communicate with our customers. From formulations through to consumer-facing claims, Bethany remains a joy to work with, always on hand to expertly offer tailored regulatory advice.

Heather, Head of Marketing

Quotation Marks

Frequently Asked Questions

Not sure about something? Check our FAQ for answers to the most common questions about compliance, documentation, and regulations.

  • We provide end-to-end regulatory solutions, including product registrations, compliance documentation, technical file creation, labeling reviews, marketing claims verification, and appointment of UK/EU Responsible Persons.

  • We specialize in regulatory compliance for medical device manufacturers, cosmetics companies, and food supplement producers.

  • We manage the entire registration process, from documentation preparation to regulatory submissions, approvals and post market compliance.

  • We monitor regulatory updates and changes to ensure our clients’ products remain compliant with the latest requirements.

  • Timelines vary depending on the product type and regulatory body, but we aim to streamline the process and keep you informed every step of the way.

  • Yes, we assist with the implementation of QMS, including ISO 13485, ISO 9001, ISO 22716 and HACCP to ensure product quality and compliance.