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.