Post-Brexit Medical Device Regulation- All You Need to Know

Some changes have occurred Post-Brexit that you should be aware of and we’ll explain how the new medical device regulations will affect your devices. Pre-Brexit, the United Kingdom was a member of European Union (EU). As such they were obligated to transpose the EU Medical Devices Directive into UK national law. Post-Brexit, that obligation no longer exists and the UK is free to chart its own path forward.

Post-Brexit Medical Device Regulations

Some changes have definitely occurred that you should be aware of and we’ll outline some commonly asked questions about Post-Brexit medical device regulation and how the process will work moving forward.

NOTE: This article is intended for companies located outside the UK and applies to devices sold in England, Scotland or Wales (collectively known as Great Britain). It does not cover the specific requirements for Northern Ireland which is part of the United Kingdom but follows EU MDR requirements.

Is the UK MDR is the same as the EU MDR?

First things first, despite the name the UK Medical Device Regulations (UK MDR 2002) is not a copy of the new EU Medical Device Regulation (2017/745). In fact, it mostly emulates the old EU MDD, IVDD and AIMDD regulations. That being said, the UK MDR 2002 was amended in 2019 and 2020, with new requirements such as:

• • All devices and IVDs sold in the UK need to be registered with the MHRA
  • New UKCA Marking will replace CE Marking after June 30, 2023
  • Manufacturers outside the UK must appoint a UK Responsible Person and UK importer
  • Only UK-based Certification Bodies can certify devices to the UK MDR

_________________________________

Updates from June 2023:
The UK government has made changes to the UK MDR (2002) to extend the acceptance of CE marked medical devices on the Great Britain market. Those amendments will enter into force on 30 June 2023. (full legal text: The Medical Devices (Amendment) (Great Britain) Regulations 2023 (legislation.gov.uk)).  

Under the new amendments, the timelines for placing CE marked medical devices on the Great Britain market are as follows: 

• • Medical devices compliant to the EU MDD or EU AIMDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2028. 
  • IVDs compliant with the EU IVDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2030. 
  • General medical devices, including custom-made devices, compliant with the EU MDR, and IVDs compliant with the EU IVDR can be placed on the market until 30 June 2030. 

_________________________________

UK MDR and the MHRA registration process

These are some of the most common questions we get asked by clients about the UK MDR and the MHRA registration process.

Is the UK the same as Great Britain?

No. The United Kingdom consists of England, Scotland, Wales and Northern Ireland. Great Britain includes England, Scotland and Wales only. The UK MDR – despite the name – only applies in Great Britain. The EU MDR applies in Northern Ireland, primarily because it shares a critical land border with Ireland which is an EU member state. More on Northern Ireland.

Do we need to register our medical device or IVD with the UK MHRA?

Yes. Because the UK is no longer part of the European Union, the MHRA requires all medical devices and IVDs to be sold in Great Britain to be registered, even if they have been sold there for decades. Those registrations can only be submitted by your local UK Responsible Person and should not be considered an approval by the MHRA. Registration is required whether or not you are pursuing certification to the UK MDR or are selling your device under CE Marking during the transition period that ends June 30, 2023.

What is the UKCA Mark?