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 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.

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.