Steps to sell in the UK
A UKRP guidance as per MHRA

With all the changes in UK medical device regulations, having a regulatory strategy is the first step to marketing medical devices and more products in the United Kingdom. Our team of expert consultants in medical device regulations, specifically the UK Medicines and Healthcare products Regulatory Agency (MHRA), will guide you through this process. We as UKRP can help you.

UKCA obtention

Identify the UK Regulatory Pathway

Before selling in the UK, each product must be correctly classified and assessed against the applicable UK requirements.

AF Pharma Service reviews your product category, intended use, claims, ingredients, technical information and target market to confirm the correct UK route.

Depending on the product, this may include MHRA registration and UKCA requirements for medical devices and IVDs, SCPN notification and UK Responsible Person requirements for cosmetics, Amazon compliance documentation, general product safety requirements, or food supplement label and claims review.

Correct classification helps avoid delays, rejected listings, non-compliant claims and missing documentation.

Best UKRP

Appoint UK Responsible Person (UKRP)

Many products sold in the UK require a UK-based responsible person, representative, importer or compliance contact.

AF Pharma Service can act as UK Responsible Person (UKRP) for medical devices and IVDs, and provide UK Responsible Person or compliance support for cosmetics, Amazon products, general consumer products and food supplements.

We help companies understand who must appear on the label, what documentation must be available, and what obligations apply before the product is placed on the UK market.

Having the correct UK contact in place is essential for product compliance, authority communication and market access.

MHRA Registration

Prepare the UK Compliance Documentation

Once the regulatory pathway is confirmed, the required product documentation must be prepared and reviewed.

AF Pharma Service supports companies with UK compliance files for medical devices, IVDs, cosmetics, Amazon products, general consumer products and food supplements.

Depending on the product, this may include technical documentation, Declaration of Conformity, UKCA documentation, PIF, CPSR, SCPN notification, label and claims review, warnings, instructions for use, test reports, supplier evidence, Amazon compliance files, or product safety documentation.

A complete documentation file helps reduce regulatory delays, Amazon compliance issues and authority questions.

Register, Notify and Place the Product on the UK Market

The final step is to complete the applicable UK registration, notification or compliance process before selling the product.

AF Pharma Service supports MHRA registration for medical devices and IVDs, SCPN notification for cosmetics, Amazon documentation submissions, general product safety compliance, and food supplement label and claims review where required.

We also review labels, claims, warnings, instructions for use and responsible person details to help ensure the product is ready for the UK market.

Once the documentation, responsible person details and registration or notification steps are completed, your product can be placed on the UK market with greater confidence.

EU Steps

UK Medical Device Regulatory Support

The United Kingdom has its own medical device regulatory framework following Brexit. Companies placing medical devices or IVDs on the UK market must comply with UK requirements, including MHRA registration, UK Responsible Person (UKRP) appointment, UKCA marking, technical documentation, labelling and post-market obligations. AF Pharma Service supports medical device and IVD manufacturers with clear, practical regulatory guidance for the UK market. Our team helps non-UK manufacturers understand the applicable requirements, define the correct regulatory pathway and prepare the documentation needed to place products on the market.

Our UK medical device regulatory services include:

medical device and IVD classification review;
UK Responsible Person (UKRP) services;
MHRA registration support;
UKCA marking strategy;
technical file and design dossier review;
Declaration of Conformity review;
labelling and IFU compliance assessment;
post-market surveillance and vigilance support;
quality management system and ISO 13485 support;
regulatory gap assessment for UK market access.

We help manufacturers assess the correct conformity route, identify whether Notified Body / Approved Body involvement is required, and prepare the technical documentation needed to support UK compliance. Our consultants also support post-market requirements, including complaint handling, vigilance reporting, PMS procedures and quality system alignment, helping companies maintain compliance throughout the product lifecycle.

AF Pharma Service also reviews UK labelling, instructions for use, responsible person details and translation requirements to ensure that product information is clear, compliant and suitable for the UK market. By working with AF Pharma Service, manufacturers can reduce regulatory uncertainty, avoid unnecessary delays and prepare a stronger compliance file for UK market entry. Contact us to discuss your UKRP, MHRA registration or UKCA marking requirements.