MHRA Registration

If a medical device or In-Vitro Diagnostic device manufacturer sells, leases, lends or gifts a device in the UK market, there is a requirement of the UK MDR 2002, that you inform the MHRA before you place your device on the market in Great Britain. If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a place of business in the UK. UKCA mark approved bodies tasks will vary depending on the classification of the concern products and the conformity assessment route a manufacturer has chosen. The conformity assessment procedures will be based on the Annexes as defined within the Medical Device Regulations 2002. The following are the devices that can be registered with MHRA.

• 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

When to register

Where the manufacturer is in the UK or the Authorized Representative is in Northern Ireland, the following devices should be registered with the MHRA presently (no grace period):

• Class I devices
• custom-made devices
• general IVDs
• all IVDs undergoing performance evaluation
• systems and procedure packs

The following devices must be registered with the MHRA from 1 May 2021:

• active implantable medical devices
• Class III medical devices
• Class IIb implantable medical devices
• IVD List A products

The following devices must be registered with the MHRA from 1 September 2021:

• Class IIb non-implantable medical devices
• Class IIa medical devices
• IVD List B products
• self-test IVDs

The following devices must be registered with the MHRA from 1 January 2022 where they have not previously been required to register with the MHRA (manufacturer or Authorized Representative is not based in the UK):

• Class I medical devices
• custom-made devices
• general IVDs
• systems and procedure packs

Information required when registering your devices with the MHRA

You are asked to provide the following type of information when registering your devices with us. Please note these lists are non-exhaustive.

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).
• a letter of designation for UK Responsible Persons (where applicable). This must be a legal contract, stating that you are the exclusive UK Responsible Person acting for the manufacturer and specifying the mandatory tasks you are contracted to undertake on behalf of the manufacturer. The mandatory tasks that must appear in the designation contract can be found in our  regulatory guidance for UK Responsible Persons.

Device details:

• which regulations apply
• 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
• UDI-DI (if applicable)
• UK Approved Body (or EU Notified Body) where applicable
• attributes such as sterility, contains latex, MRI compatible

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

How to register in MHRA

• Apply to register on the Device Online Registration System (DORS)

Create MHRA account request by filling details using following link 

https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration 

• confirmation will come about the account request has been accepted or rejected
• A statutory fee of £100 applies for each registration application
• If you need to update any information within an existing registration, you will be charged a £100 statutory fee.
• Once registered, your company name and address are added to the Public Access Database for Medical Device Registration.

The MHRA registration database contains manufacturer name, address, MHRA reference (account) number, all the devices registered by GMDN term and link is as follows

  https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200 

Renewal of MHRA registration

MHRA Registration must be renewed one year after your registration application or confirmation was made and every two years after this date. If your registration is failed to renew, there will be removal of your records from the MHRA database. After which you need to apply for a new registration or you will no longer be able to place your device on the UK market.