Placing A Medical Device On The Great Britain, Northern Ireland And European
Union (EU) Markets From 1 January 2021
From 1 January 2021 the Medicines and Healthcare
products Regulatory Agency (MHRA) will take on the responsibilities for the UK
medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK
system will operate, including for:
• Getting your device certified
• Conformity marking your device
• Registering your device with the MHRA
This guidance is divided into sections on the
different rules that will apply in Great Britain, Northern Ireland and the EU.
Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules will apply to
those in Great Britain after the transition period. For more information on the
regulatory system for medical devices in Northern Ireland, please see
‘Regulation of medical devices in Northern Ireland’
This guidance does not cover other ‘New Legislative
Framework’ products, which are subject to separate guidance.
The proposals outlined in this guidance notice will
take effect through legislative changes that will be introduced later in 2020.
They are still therefore subject to parliamentary approval.
This information is meant for guidance only. You
should consider whether you need separate professional advice before making
Summary of key requirements for placing a device
on the Great Britain market
From 1 January 2021, there will be a number of
changes to how medical devices are placed on the market in Great Britain. These
• CE marking will continue to be used and recognised
until 30 June 2023
Certificates issued by European Economic Area (EEA)-based
Notified Bodies will continue to be valid for the Great Britain market until 30
A new route to market and product marking will be
available for manufacturers wishing to place a device on the Great Britain
market from 1 January 2021
From 1 January 2021, all medical devices and in
vitro diagnostic medical devices (IVDs) placed on the UK market will need to be
registered with the MHRA. There will be a grace period for registering:
4 months for Class IIIs and Class IIb implantables,
and all active implantable medical devices
8 months for other Class IIb and all Class IIa
12 months for Class I devices
The above 12-month grace period will not apply to
manufacturers of Class I devices and general IVDs that are currently required to
register with the MHRA.
If you are a manufacturer based outside the UK and
wish to place a device on the UK market, you will need to establish a UK
Responsible Person who will take responsibility for the product in the UK.
Further detail on the UK Responsible Person is set out below.
The information as given on the weblink
includes the following :
Legislation that will apply to Great Britain
The EU Medical Devices Regulation (MDR) and EU in
vitro Diagnostic Medical Devices Regulation (IVDR) from 1 January 2021
The role of the MHRA
Requirements for those manufacturing and
supplying devices in the UK
Regulation of medical devices in Northern Ireland
Placing a medical device on the EU market
CE marking for the EU market after the transition
Qosina Partners with Resolution
Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing
Ronkonkoma, NY, USA, October 6, 2020—Qosina is
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