MHRA Registration Consultants

Work with experienced MHRA registration consultants to support the registration of your medical devices and IVDs in the UK. Cert3Global provides structured regulatory support from documentation review to submission helping manufacturers prepare for market entry in Great Britain.

Our MHRA registration consulting services are designed for global manufacturers, including support for UK Responsible Person (UKRP) coordination, technical documentation, and regulatory submissions.

Expert MHRA Registration Support for the UK Market

Entering the UK market requires registration of medical devices, IVDs, and certain healthcare products with the MHRA (Medicines and Healthcare products Regulatory Agency). Under UK regulations, devices must be registered before they are placed on the market in Great Britain.

Cert3Global provides structured MHRA registration support to assist manufacturers throughout the process from classification and documentation to submission and post-market considerations.

For manufacturers based outside the UK, registration is typically completed through a UK Responsible Person, who acts as the official representative for regulatory communication.

Our approach focuses on clarity, accuracy, and regulatory alignment to support efficient registration processes.

What is MHRA Registration?

MHRA registration is a regulatory requirement for medical devices, in vitro diagnostic devices (IVDs), and certain healthcare products before they can be marketed in Great Britain.

Manufacturers are required to submit product and company information through the MHRA’s Device Online Registration System (DORS), including classification details, conformity declarations, and relevant documentation.

For non-UK manufacturers, this process is carried out via a UK Responsible Person, who submits the registration and acts as a liaison with the MHRA.

Why is MHRA Registration Important?

MHRA registration is necessary for placing products on the UK market. Without registration, devices cannot be legally supplied in Great Britain.

A structured approach to registration helps:

MHRA Registration Services You Can Rely On

Our MHRA registration consultants provide complete regulatory support—from initial assessment to ongoing compliance – ensuring your products are fully aligned with UK requirements.

MHRA Registration Process

Our MHRA registration consultants follow a structured approach to ensure efficient and compliant submissions:

Appoint UK Responsible Person (if required)

Non-UK manufacturers must appoint a UKRP to handle registration and compliance.

Device Classification

Determine whether your product falls under Class I, IIa, IIb, III, or IVD categories.

Documentation Preparation

Prepare technical files, declaration of conformity, labeling, and product data.

MHRA Submission

Submit your application through the DORS system with all required details.

Registration Confirmation

Once approved, your device is listed in the MHRA database.

Ongoing Compliance

Maintain updates, incident reporting, and documentation as required.

MHRA may request additional technical documentation during review to verify compliance.

Who Needs MHRA Registration?

MHRA registration is required for:

If your business is located outside the UK, you must appoint a UK Responsible Person to complete the registration on your behalf.

Why Choose Cert3Global as Your MHRA Registration Consultants?

Cert3Global offers a comprehensive approach to MHRA registration, combining regulatory expertise with practical business support.

What sets us apart

Experienced MHRA registration consultants
End-to-end compliance support
Expertise in medical devices and IVDs
Seamless UKRP coordination
Fast and accurate submission process
Ongoing regulatory support

We don’t just help you register—we help you stay compliant and competitive in th UK market.

Get Expert MHRA Registration Support Today!

Navigating MHRA registration can be complex, especially for non-UK manufacturers. With Cert3Global’s MHRA registration consultants, you gain a reliable partner who ensures compliance, reduces delays, and simplifies the entire process.

Whether you need support with documentation, submission, or UK Responsible Person coordination, we provide tailored solutions for your business.

FAQs

Is MHRA registration mandatory?

Yes, all medical devices and IVDs must be registered with the MHRA before being placed on the UK market.

Do non-UK manufacturers need a UK Responsible Person?

Yes, non-UK manufacturers must appoint a UK Responsible Person to handle MHRA registration and compliance.

How long does MHRA registration take?

Timelines vary depending on product type and documentation readiness, but proper preparation can significantly reduce delays.

What documents are required for MHRA registration?

Technical documentation, declaration of conformity, product details, and manufacturer information are required.

Can MHRA registration be updated?

Yes, any changes to device details or classification may require updates or re-registration.

Disclaimer

Cert3Global provides regulatory consulting and support services. Registration outcomes, timelines, and market access remain subject to applicable UK regulations and MHRA processes.