The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK.

You must register with the MHRA if you or your company sells, leases, lends or gifts:

  • Class I, IIa, IIb or III medical devices you have manufactured
  • Class I, IIa, IIb or III medical devices you have refurbished or re-labelled with your own name
  • any system or procedure pack containing at least one medical device
  • custom-made devices
  • in vitro diagnostic medical devices (IVDs) you have manufactured
  • IVDs undergoing performance evaluation

It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your medical device on the market in England, Scotland and or Wales.

You will need the  information to complete the registration:

Manufacturer details: 

  • legal entity name and address as it appears on the device labelling/packaging.
  • company type e.g., limited company, sole trader.
  • administrative contact (you can have up to 15 people with access).

Device details:

  • which legislation applies.
  • the class of device you are registering.
  • Global Medical Devices Nomenclature (GMDN)® Code and Term to describe your device.
  • Basic UDI-DI (if applicable)
  • medical device name (brand/trade/proprietary name).
  • model or version detail.
  • catalogue/reference number.
  • UK Approved Body (or EU Notified Body) where applicable.
  • attributes such as sterility, contains latex, MRI compatible.

You will also need to provide a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable.

You will not be regarded as registered with the MHRA until you have provided details of the device you are registering and have received confirmation that your device is registered. You must ensure all information registered with the MHRA is accurate and up to date.

To do this you first need to register your organisation with a manufacturer’s account with the MHRA’s Device Online Registration Service (DORS).

DORS can be accessed here: https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration

Registration instructions are shown over the page and a comprehensive DORS user reference guide is available here.

The device.registrations@mhra.gov.uk address may be used to resolve any registration queries.

You can delete an application at any stage before submitting to MHRA. This will delete all devices in the application.

DORS initial account registration

1. Complete the organisation details selecting the Manufacturer organisation role.

2. Select the appropriate primary reason for requesting an MHRA.

3. Submit the form. A successful submission will be confirmed with the following response:

If your request is accepted, you will receive two emails:

  1. A welcome email with subject line Account creation – outcome, from email address no-reply@mhra.gov.uk with instructions on initial actions
  2. Email with subject line MHRA Portal account creation from email address admin@mhrabpm.appiancloud.com containing your username (usually firstname.lastname), a temporary password and a link to the system.

Log in for the first time on a laptop or PC not a mobile or tablet.

Registering a Device in the UK

Once you have access to DORS and reviewed the manufacturers information, devices can be added in bulk or individually. To register a single device:

1. Select Add Device.

2. Enter the medical device name and model or catalogue reference. The Model/Version and Catalogue/Reference data cannot be the same. You must enter either Model/Version or Catalogue/Reference or both. You cannot select No for both fields.

3. Declare your device type.

4. Enter the Global Medical Device Nomenclature (GMDN) code. If you are unsure about your GDMN code read this. Making any changes at GMDN Term or Code level in an application will result in the product information being removed and you will need to add product again.

5. Select the applicable directive.

6. Select appropriate answers for the mandatory questions including the risk classification and any optional questions as desired. The MHRA encourages answers to optional questions however these are not obligatory. Software as a medical device should answer yes to the question: Are any of the products related to this device active.

7. Click Continue or Save and Exit. The Continue button will not be enabled until you have answered all the mandatory questions.

8. Upload a conformity assessment certificate or if your device is a non-sterile, non-measuring, non-reprocessed, device within the class I risk category and does not require a conformity assessment certificate issued by a UK Approved Body or EU Notified Body, you must upload a delf-certification conformity declaration.
For each custom-made device that does not require a conformity assessment certificate, you need to upload a custom-made statement.

Files should not exceed 15 Mb and should be in an approved .doc, .docx, .jpg, .pdf, .png,. odt, .tif format.

9. Select the appropriate conformity assessment from the drop-down menu.

10. Add a Document Reference of your choice. This must not contain any special characters other than hyphen (-) or underscore (_) otherwise the document will not upload.

11. Upload the file.

12. Select Continue.

13. Review information, accept the terms and conditions and proceed to payment.

14. Once payment has been processed, click the Submit button to submit the application. You will receive a confirmation email informing you that you application has been submitted and an on-screen confirmation message will appear if successful.

Within 5 working days from, you should receive an email confirming the outcome of the application. In the meantime, you can check the status of your application in the Applications Tab , however the registration status will not change until reviewed by the MHRA.

Completed registrations will appear on the Public Access Registration Database (PARD), usually the week after completion