Businesses wishing to sell medical devices to the UK market must ensure regulatory compliance in the UK. Such regulation relates, amongst other things, to product safety, supply chain transparency and import/export control.
Please note however that from the end of the Brexit transition period, medical devices sold in Northern Ireland will be subject to a separate regulatory regime to the rest of the UK.
What is a medical device?
EU Directive 93/42/EEC on Medical Devices (EU MDD), describes a medical device as any instrument, apparatus, appliance, software, material or other article used alone or combined for humans to:
- Diagnose, prevent, monitor, treat or alleviate disease
- Diagnose, monitor, treat, alleviate or compensate for an injury or handicap
- Investigate, replace or modify the anatomy or a physiological process or
- Control conception
How are medical devices regulated in the UK?
Currently, medical device regulation in the UK is drawn from EU law.
From the end of the Brexit transition period however, EU law will cease to have effect in the UK. By virtue of the European Union (Withdrawal) Act 2018 (EUWA) and the European Union (Withdrawal Agreement) Act 2020 (EUWAA) (EUWA and EUWAA together being the Withdrawal Acts), most EU law in force at the point the transition period expires, will form a new body of "retained EU law" in the UK. This includes most EU medical device regulations.
Separately, the EU is currently undergoing a substantial reform of its medical device regulation. Certain of these reforms were due to take effect in 2020 (and so would have become "retained EU law" when the Brexit transition period expires), however due to COVID-19, these reforms have been delayed, and will no longer become UK law.
The future framework of medical device regulation in the UK has thus changed significantly in the past few years. To add clarity, we have therefore set out a high level overview of the changes to medical device regulation in the UK and EU in the coming months/years.
The current position – until 1 January 2021
Until the Brexit transition period expires, the UK continues to be subject EU medical device regulation. In particular:
- EU Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- EU Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) and
- EU MDD
have been implemented into UK law by the Medical Device Regulations 2002 (2002 Regulations).
Changes to EU medical device regulation (not applicable in the UK)
A fundamental overhaul of medical device regulation is currently underway in the EU. The EU AIMDD, EU IVDD and EU MDD are set to be replaced by the new EU Medical Device Regulations 2017/745 and the EU In vitro Diagnostics Regulations 2017/746 (together, the "Regulations"). For more information on these changes please see here.
Aspects of the Regulations were due to become fully effective on 26 May 2020, and would therefore have formed part of UK law once the Brexit transition period expires. However due to COVID-19, the EU decided to postpone the application of the Regulations by one year (for more information on this postponement, see here).
As the Regulations will no longer take effect until 26 May 2021 (i.e. after the Brexit transition period has ended), they will not be automatically become "retained EU law" under the Withdrawal Acts, and will therefore never be applicable in the UK.
The position from 1 January 2021
The EU AIMDD, EU IVDD and EU MDD were implemented in the UK by the 2002 Regulations, which will continue to apply in the UK as "retained EU law" by virtue of the Withdrawal Acts. However, the 2002 Regulations will be amended by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, to remove those elements of the 2002 Regulations particular to the EU.
Consequently, there will be operational changes to how medical devices will be regulated in the UK e.g. the MHRA will take a more central role as regulator. For more information on these changes, please see the recently issued government guidance here.
It should also be noted that the UK government has committed to strengthen the regulation of medical devices in the UK, and to that end, a new Medicines and Medical Devices Bill has been introduced to Parliament. The extent to which this new Medicines and Medical Devices Bill will align the UK’s regulatory regime with that of the EU remains unclear.
Businesses should ensure that they are ready for the changes to medical device regulation that will take effect in the UK from 1 January 2021. Equally, businesses should also be mindful that this regulatory regime is due to change when the Medicines and Medical Devices Bill is passed into law.