Medicines Healthcare Products Regulatory Agency
Overview
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, 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 apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.
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 orUKCAmarked products, which are subject to separate guidance.
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.
As expanded on in the implementation update on work towards a strengthened future medical devices regime, the government has put in place legislation to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
Summary of key requirements for placing a device on the Great Britain market
Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:
- a new route to market and product marking (theUKCAmarking) is available for manufacturers wishing to place medical devices on the Great Britain market
- all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with theMHRAbefore they are placed on the Great Britain market
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if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person is set out below
- A valid CE mark is a CE marking that enables the medical device to be placed on the EU market. The Government has introduced measures which provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificateor 30 June 2028
- in vitrodiagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
- general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
- the EU no longer recognises UK Notified Bodies
- UK Notified Bodies are not able to issue CE certificates - and have become UK Approved Bodies
Legislation that applies in Great Britain
Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UKMDR2002) which, prior to the end of the transition period (following the UKs departure from the EU), gave effect in UK law to the directives listed below:
- 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)
This means that the current Great Britain route to market andUKCAmarking requirements are based on the requirements derived from the above EU legislation.
The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation
Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EUMDR) has applied in EU Member States and Northern Ireland. The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EUIVDR) has applied in EU Member States and Northern Ireland since 26 May 2022. As these EU regulations did not take effect during the transition period, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not apply in Great Britain.
There is further information below on how devices that have already been registered with theMHRAunder the EUMDRor the EUIVDRare regulated.
The role of theMHRA
TheMHRAperforms market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK.
TheMHRAis responsible for the designation and monitoring of UK conformity assessment bodies.
Further guidance is available on how theMHRAenforces the legislation on medical devices.
Requirements for those manufacturing and supplying devices in Great Britain
Manufacturers wishing to place a device on the Great Britain market need to register with the?MHRA. More information on registrations (including fees) can be found in the MHRAs registrations guidance.
Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. See guidance on UK Responsible Persons below for more information.
Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices. See below for guidance on theUKCAmarking and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information.