Mhra application form 2026

See details

4 out of 5

38 votes

The document outlines the registration process for medical devices in the UK under the Medical Devices Regulations 2002. It includes instructions for completing Form RG2, which requires details about the manufacturer, device information, and payment methods. The form is used to notify the MHRA of new registrations or changes to existing ones, ensuring compliance with regulatory requirements. Guidance on categorizing devices and associated fees is also provided.

Here's how it works

01. Edit your mhra application form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send mhra form via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out mhra application form with our platform

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open the mhra application form in the editor.
Begin by entering the date of notification in Part 1. Ensure you indicate whether this is a first registration or a change of information.
In Part 1, select the status of your organization by ticking the appropriate box: Manufacturer, Authorised Representative, etc. This helps clarify your role in the registration process.
Complete the declaration section by printing your full name and signing it as an authorized signatory. This confirms that all provided information is accurate.
Move to Part 2 and enter the full name and postal address of the manufacturer or responsible person. Ensure all contact details are accurate for effective communication.
In Part 3, provide payment information. Select your payment method and ensure to attach any necessary transaction receipts for timely processing.
Finally, review all sections for completeness before submitting via email or post as indicated at the end of the form.

Start using our platform today to streamline your mhra application process effortlessly!

See more mhra application form versions

We've got more versions of the mhra application form form. Select the right mhra application form version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2015	4.8 Satisfied (282 Votes)
2013	4 Satisfied (38 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What does MHRA stand for?

Medical devices, including IVDs and custom-made devices, need to be registered with the MHRA after they have been certified by an UK approved body, an EU notified body, or where they have been self-certified, and prior to being put onto the UK market. The MHRA performs market surveillance of medical devices in the UK.

What are the MHRAs main functions?

Our responsibilities are to: ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness) secure safe supply chain for medicines, medical devices and blood components.

What products need to be registered with MHRA?

The MHRA regulates medicines, including vaccines, supplied in the UK. Our activity spans the whole of a medicines lifecycle. We decide whether medicines should be granted licences (also known as Marketing Authorisations) and whether licences can be varied as information about the medicines develop.

What is MHRA certification?

Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) only and therefore, companies will no longer need to apply for, or maintain, separate licenses for Great Britain (GB) and NI to market novel medicines.

What is the purpose of the MHRA?

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

piggyback application mhra

Mhra application form online Mhra application form variation MHRA approval process MHRA SmPC template Mhra Marketing authorisation list MHRA Submission portal MHRA WDA application MHRA Submissions

What is the MHRA equivalent in the US?

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) and the Food and Drug Administration (FDA) of the United States of America (US) are the regulatory authorities (collectively, the regulatory authorities) with responsibility in their respective countries for the authorization,

Who needs to register with MHRA?

Regulation Registering your medical device with MHRA Medical devices, including IVDs and custom-made devices, need to be registered with the MHRA after they have been certified by an UK approved body, an EU notified body, or where they have been self-certified, and prior to being put onto the UK market.