Remember the good old days when the Medical Device Directive ruled and the United Kingdom was “united” with the rest of Europe? Alas, relationships often get complicated. And they did. In 2016 when UK voters decided to cut the cord with their continental counterparts, it set in motion a bureaucratic tidal wave to dislodge the UK from Europe laws and conventions. The outcome? As of December 31, 2020, the medical device regulations of the European Union no longer applied. The United Kingdom is now considered a “third country” to the EU, much like Switzerland.
Device Manufacturers Must Now Register with the UK MHRA
For medical device companies selling in the UK, existing CE Marking certificates will continue to be recognized until 30 June 2023 and after that date CE Marking will no longer be recognized. You will need to place the UKCA Mark on your devices and be audited by a UK Conformity Assessment Body. Before you get too complacent, you must do the following before the end of 2021 (earlier in many cases):
Appoint a UK Responsible Person – Very similar responsibilities to the EU Authorized Representative and responsible for registering your devices with the MHRA. Must be located in the UK.
Appoint a Great Britain UK Importer – Responsible for placing your products on the market in England, Wales or Scotland. Only required for companies with no registered location in Great Britain.
Register with the MHRA – Here’s more information from the MHRA on how that works. In a nutshell, all manufacturers must create an account on the UK Device Online Registration System (DORS) and have their devices registered by the end of 2021.
What’s the Difference Between the UK and Great Britain? And what about Northern Ireland?
A quick geography lesson because it’s highly relevant. The UK is comprised of four non-sovereign “countries” (England, Wales, Scotland and Northern Ireland) collectively known as the United Kingdom. Great Britain is the main island of the UK and includes England, Wales and Scotland. Why does this matter? Northern Ireland (part of the UK) and Ireland (an EU member country), share a border. To ensure the uninterrupted flow of goods across that border, some special concessions needed to be made between the UK and EU. One such agreement was that medical device companies exporting to/from Northern Ireland will follow some aspects of the EU Medical Device Regulation. We could quickly cure insomnia explaining the mechanics of that situation but just know that Northern Ireland is given special treatment even though it is part of the UK. If you export there, read this.
Why a UK-based Importer is Needed to Sell in Great Britain
Even though CE Marked devices will be accepted in the UK until mid 2023 you are still required to register your devices (even Class I devices) with the MHRA by the end of 2021. Assuming you have no office in the UK, those registrations need to be done by your UK Responsible Person who will in turn make sure you have appointed an importer, if they are not also acting in that capacity. Also, due to the Northern Ireland situation, there actually is no such thing as a UK Importer. The MHRA refers to the role as a Great Britain Importer. Your importer performs many of the same responsibilities of an EU importer including:
Verify that devices sold in England, Wales or Scotland carry the CE or UKCA Mark
Verify UK declaration of conformity and technical documentation
Verify proper conformity assessment procedure has been performed
Verify labelling and accompanying information (IFU)
Verify that manufacturer has assigned UDI
Verify that UK MMDA storage and transportation requirements are fulfilled
Maintain a register of complaints as required by law
Inform manufacturer if device provides serious risk/is not in conformity
Check to ensure that devices have been registered with MHRA
Report to MHRA regarding serious incidents or risks
Cooperate with MHRA regarding preventative/corrective action
Check identification of devices within the supply chain
Get on Board Soon with UK Requirements
While the MHRA requirements are evolving, it’s best make sure your company and devices are registered in DORS as soon as possible. Due to the limited number of UK Conformity Assessment Bodies, you will also want to start talking to them soon about the process of obtaining the UKCA Mark for your devices.