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.
Medical devices sold in Northern Ireland are currently subject to a separate regulatory regime to the rest of the UK. Given these differences, and the prospect of changes to the regime in Northern Ireland, this article only covers the current position in Great Britain.
What is a medical device?
The Medical Devices Regulations 2002 (UK MDR) describe 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
- Control conception
How are medical devices regulated in the UK?
The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, is responsible for regulating the UK medical devices market.
Medical device regulation in the UK is governed by the UK MDR, which implements various EU medical device regulations, including:
- 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)
- EU Directive 93/42/EEC on medical devices (EU MDD)
Post-Brexit, much of the EU medical device regulation has been retained as UK domestic law, although the UK MDR was amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to remove elements particular to the EU.
Changes to EU medical device regulation (not applicable in the UK)
The EU has undergone recent reforms to its medical device regulation, comprising the Medical Devices Regulation (EU) 2017/745 which became fully applicable in May 2021 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 which entered into force in May 2022. As these reforms took effect after the expiry of the Brexit transition period, they have not become UK law.
There are three elements in relation to the new regime that businesses need to take particular note of:
- Businesses operating under a European conformity assessment and approval (CE mark) will now need to carry out a UK-specific conformity assessment and approval (UKCA mark). That can be challenging where the device requires independent approval from a so-called UK-approved body, and complications have led to significant delay to UK government deadlines in this regard.
- The new regime may require the establishment in, or the use of a third-party representative in, the UK for EU based businesses.
- There is now divergence between the UK and the EU, developments will need to be kept under review for businesses that operate across borders.