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.
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):
The following devices must be registered with the MHRA from 1 May 2021:
The following devices must be registered with the MHRA from 1 September 2021:
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):
You are asked to provide the following type of information when registering your devices with us. Please note these lists are non-exhaustive.
You also need to provide a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable.
How to register in MHRA
Create MHRA account request by filling details using following link
The MHRA registration database contains manufacturer name, address, MHRA reference (account) number, all the devices registered by GMDN term and link is as follows
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.
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