MEDICAL DEVICES LEGAL FRAMEWORK IN THE EU AND UK
After 31 of December 2020 (end of the so-called ‘transition period’), the United Kingdom (UK) will be considered a third country and not a Member State of the European Union, meaning that all EU rules and regulations will no longer be applied to medical devices placed in the UK market. After the transition period, the rules for Northern Ireland will be different from those in Great Britain, as EU rules will continue to apply in this country (e.g. CE marking, EU-based manufacturer or Authorized Representative).
At the moment, medical devices are regulated under Directive 90/385/EEC (on active implantable medical devices – EU AIMDD), Directive 93/42/EEC (on medical devices – EU MDD) and Directive 98/79/EC (on in vitro diagnostic medical devices – EU IVDD), which are given effect in the 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 will exist on January 1st 2021) will continue to have effect in Great Britain after the transition period.
In 2017, two Regulations on medical devices and in in vitro diagnostic medical devices entered into force in the European Union (EU) and started to replace the three existing Directives, establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. The EU Medical Devices Regulation (MDR – Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR – Regulation (EU) 2017/746) will fully apply from 26 May 2021 and 26 May 2022, respectively. As these regulations will not take effect until after the transition period with the EU has ended, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain.
After the transition period, medical devices manufactured in the United Kingdom and placed on the EU market will be regarded as products imported form a third country. In this sense, manufacturers from the UK will need an Authorized Representative and importer located in the European Union. On the other hand, if a manufacture is based outside the UK and wishes to place a medical device on the UK market, it will need to establish an UK Responsible person, who will take the responsibility for the device in this country.
CHANGES FOR MEDICAL DEVICES PLACED IN THE UK
For medical devices placed in Great Britain, there will be some changes, beginning on January 1st 2021. From this date, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the sole authority responsible for medical devices marketed in the UK. MHRA is the designated competent authority that administers and enforces law on medical devices in the UK.
- CE Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until June 30th, 2023.
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from January 1st 2021.
- From January 1st 2021, all medical devices and in vitro diagnostic medical devices placed on the UK market will need to be registered with the MHRA. Grace periods will be granted for the registration:
- 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 devices.
- 12 months for Class I devices (do not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA).
- The need for an UK Responsible Person if the manufacture is based outside this country and this manufacture will first need to register with the MHRA.
From 1st January 2021, all medical devices, IVD or custom-made devices need to be registered with MHRA, before being placed on the UK market.
Notified Bodies on the UK will no longer be able to issue CE Mark certificates. The UK Conformity Assessed (UKCA) mark is a new UK product marking that will be applied to medical devices (and other products) being placed in the UK after the transition period. From 1st July 2023, the medical device being marketed in the UK will need to fulfil the requirements for placing the UKCA mark. This UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets and products which are required to have a CE marking will continue to have this requirement to be sold in these markets.
Finally, manufacturers will be required to submit vigilance reports to the MHRA if the medical device is placed in the UK when certain incidents with their device occur in this country.
- Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, 19 October 2019. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840655
- Medicines and Healthcare products Regulatory Agency (MHRA) – Guidance – Regulating medical devices from 1 January 2021. Available at: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021#contents
- Medicines and Healthcare products Regulatory Agency (MHRA) – Medical devices: the regulations and how we enforce them. Available at: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices