MHRA Registration Services

Comprehensive support for medical device registration with the UK Medicines and Healthcare products Regulatory Agency, facilitating market access to the United Kingdom.

MHRA Registration Process

Understanding MHRA Medical Device Regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's regulatory body responsible for ensuring the safety, quality, and effectiveness of medical devices. Following Brexit, the UK has implemented its own regulatory framework for medical devices, separate from the EU's MDR.

Our MHRA registration services guide manufacturers through the UK's regulatory requirements, including the UKCA marking system, ensuring compliance and market access to the UK following Brexit.

Key UK Regulatory Changes Post-Brexit

  • Introduction of the UKCA (UK Conformity Assessed) marking
  • Establishment of the UK Responsible Person requirement
  • Creation of the MHRA as the UK's regulatory authority for medical devices
  • Implementation of the UK MDR 2002 (as amended)

MHRA Registration Process

A structured approach to UK market access

1

Regulatory Assessment

Evaluation of your device against UK regulations to determine classification, conformity assessment route, and specific requirements.

2

UKCA Marking Preparation

Preparation of technical documentation and conformity assessment to meet UKCA marking requirements, including any UK-specific differences.

3

UK Responsible Person

Assistance in appointing a UK Responsible Person (UKRP) as required for non-UK manufacturers to act as a legal representative.

4

Registration Submission

Preparation and submission of registration documents through the MHRA's online portal, ensuring compliance with all requirements.

5

Post-Market Surveillance

Implementation of UK-specific post-market surveillance requirements, including vigilance reporting to the MHRA.

6

Renewal & Compliance

Ongoing support for maintaining MHRA registration, including renewal processes and adapting to regulatory changes.

UKCA vs CE Marking

Understanding the differences for UK market access

UKCA Marking

  • Applies to:

    Medical devices placed on the UK market (Great Britain: England, Scotland, Wales)

  • Regulatory basis:

    UK Medical Devices Regulations 2002 (as amended)

  • Notified bodies:

    UK Approved Bodies for conformity assessment

  • Requirements:

    Similar to EU MDR but with UK-specific elements and UK Responsible Person requirement

CE Marking

  • Applies to:

    Medical devices placed on the EU market and Northern Ireland market

  • Regulatory basis:

    EU Medical Device Regulation (MDR) 2017/745

  • Notified bodies:

    EU Notified Bodies for conformity assessment

  • Requirements:

    EU MDR requirements with EU Authorized Representative for non-EU manufacturers

Why Choose Our MHRA Registration Services

Expert guidance for UK market access post-Brexit

UK Regulatory Expertise

Deep understanding of post-Brexit UK medical device regulations and MHRA requirements, keeping pace with evolving requirements.

UK Responsible Person Network

Established relationships with UK Responsible Persons to meet the mandatory requirement for non-UK manufacturers.

UKCA Transition Support

Expert guidance on transitioning from CE marking to UKCA marking, including understanding the latest deadlines and requirements.

MHRA Liaison Experience

Proven experience in interacting with the MHRA, including submission preparation, query responses, and regulatory meetings.

Access the UK Medical Device Market

Our MHRA experts will guide you through the UK's regulatory requirements, ensuring compliance with post-Brexit regulations and successful market entry.

Start Your MHRA Registration Journey