Medicines Healthcare Products Regulatory Agency
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 end of 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
In this guidance, medical device includes in vitro diagnostic medical devices and active implantable medical devices.
This guidance only applies to medical devices and does not cover other CE marked 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 specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.
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 are:
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- After the transition period, the EU will no longer recognise UK Notified Bodies
- UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the CE UKNI marking, which will be valid in Northern Ireland) - and will become UK Approved Bodies from 1 January 2021
- 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, including 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:
- Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
- Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices from 1 January 2021 on the same basis as they do now until the new registration requirements start to apply to those devices
- If you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint 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
Legislation that will apply in Great Britain
Legislation from 1 January 2021
Currently, devices are regulated under:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
These directives are given effect in UK law through the?Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they exist on 1 January 2021) will continue to have effect in Great Britain after the transition period has ended.
This means that from 1 January 2021, the Great Britain route to market and UKCA marking requirements will continue to be based on the requirements derived from current EU legislation.
The EU Medical Devices Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR) from 1 January 2021
The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations will not take effect until after the transition period, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain. This means that the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented in Great Britain.
The Independent Medicines and Medical Devices Safety Review, which delivered its report this July, has highlighted the importance of strengthened regulations that do more to protect patients. We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill.
We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. We will take into consideration international standards and global harmonisation in the development of our future system.
We will engage with stakeholders within the life sciences and healthcare sectors on this proposed regime. As part of these discussions, we will identify and prioritise elements of international practice that promote public health and patient safety. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system.
There is further information below on how devices that have already been registered with the MHRA under the EU MDR or the EU IVDR will be regulated.
The role of the MHRA
The MHRA will continue to perform market surveillance of medical devices on the UK market and will be able to take decisions over the marketing and supply of devices in the UK.
The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies.
Further guidance is available on how the MHRA enforces the legislation on medical devices.
Requirements for those manufacturing and supplying devices in Great Britain
From 1 January 2021,?the roles and responsibilities of those manufacturing and supplying medical devices, including IVDs, will change.
Manufacturers wishing to place a device on the Great Britain market will first need to register with the?MHRA. See guidance on registrations below for more information.
Where a manufacturer is not established in Great Britain, they will need to appoint a UK Responsible Person to register and act on their behalf. See guidance on UK Responsible Persons below for more information.