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. Some changes have definitely occurred that you should be aware of and we’ll explain how the new UK medical device registration 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.
The UK MDR is not 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
Here are 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?
The UKCA Mark is Great Britain’s version of the European CE Mark and must be placed on all medical devices and IVDs no later than July 1, 2023. European CE Marking will continue to be acceptable for devices sold in England, Scotland or Wales until June 30 but not after. Manufacturers of Class I (non-sterile/measuring) devices and General IVDs can self-certify compliance to the UK MDR 2002. In all cases, the name of the UK Responsible Person must be added to the labeling of any devices in compliance with the UK MDR.
What is a UK Responsible Person?
The UK Responsible Person is a role very similar to the European Authorized Representative. This person must be based in the UK and is responsible for registering your medical device or IVD with the MHRA, among many other things. Unlike your importer, your UK Responsible Person’s name will appear on your labeling.
What is a Great Britain (UK) importer?
The Great Britain importer must be based in England, Scotland or Wales and is responsible for placing your devices on the market. They have many of the same responsibilities outlined in Article 13 of the EU MDR and IVDR, the primary difference is that your Great Britain importer does not need to be identified on your labeling. Read more about the importer here.
Can our EU-based Notified Body certify our devices to the UK MDR?
Starting 1 July 2023, CE certificates issued by EU-based Notified Bodies will no longer be valid in Great Britain so your devices will need to be certified to the UK MDR by a UK-based Conformity Assessment Body to be sold after that date. If your European Notified Body is BSI, Intertek, SGS or UL, these companies are also approved UK conformity assessment bodies.
One company, three European markets