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MHRA guidance on registering medical devices for sale in the UK from 1 January 2021

Date: December 10, 2020

Category: Industry news

Guidance update for all medical device manufacturers, issued by the Medicines and Healthcare Products Regulatory Agency, for registering medical devices for sale in the UK.

The below highlights how to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland from 1 January 2021.

Update on the requirements

From 1 January 2021 the following devices will need to be registered with the MHRA under existing arrangements:

  • Class I medical devices
  • IVDs
  • Custom-made devices

All other classes of device placed on the Great Britain market will require registration with the MHRA, subject to grace periods, over the following 12 months, depending on the class of devices.

Registering your devices: who needs to register and when

If you intend to place your device on the UK market, you must now make note of the following:

It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain.

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

  • Class I, IIa, IIb or III devices you have manufactured
  • Class I, IIa, IIb or III 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
  • IVDs you have manufactured
  • IVDs undergoing performance evaluation

There will be a grace period to allow time for compliance with the new registration process.

The registration requirements will apply from 1 January 2021, although current registration requirements will continue to apply. You can register devices ahead of these dates, but there will be no legal obligation to do so.

What information do you need to provide the MHRA for registration?

Manufacturer details:

  • registered place of business
  • company name
  • company type e.g. limited company, sole trader
  • administrative contact (you can have up to 15 people with access)
  • copy of written evidence demonstrating appointment of UK Responsible Persons (where applicable)

Device details:

  • which regulations apply
  • the class of device you are registering
  • Global Medical Devices Nomenclature (GMDN) code and term to describe your device
  • medical device name (brand/trade/proprietary name)
  • model or version detail
  • catalogue/reference number
  • UDI-DI (if applicable)
  • UK Approved Body (or EU Notified Body) where applicable
  • attributes such as sterility, contains latex, MRI compatible
How to apply to register using the Device Online Registration System (DORS)

You will need to start by creating an account on the MHRA DORS in order to register your devices.

The MHRA will tjhen email you to confirm whether your account request has been accepted or rejected.

Useful resources to help you get started

The MHRA have provided a series of useful video resources to guide you through what you need to do. You can find the necessary video tutorials on the MHRA website for further details.