Remember 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, like Switzerland, is now considered a “third country” to the EU and must comply with the new UK MHRA requirements.
Device Manufacturers Must Now Register with the UK MHRA
Medical device companies selling in the UK will continue to be able to use existing CE Marking certificates until 30 June 2023. 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):
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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.
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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.
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Register with the UK 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.
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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, the UK and EU needed to make some special concessions. One such agreement was that medical device companies exporting to/from Northern Ireland will follow some aspects of the EU Medical Device Regulation. Explaining the mechanics of that situation, we could quickly cure insomnia. Even though Northern Ireland is part of the UK, it is given special treatment. 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, you need to register those products with 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.
Overlap of responsibilities of UK importer and EU importer
Your importer performs many of the same responsibilities of an EU importer including:
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Verify that devices sold in England, Wales or Scotland carry the CE or UKCA Mark
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Verify UK declaration of conformity and technical documentation
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Verify proper conformity assessment procedure has been performed
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Verify labelling and accompanying information (IFU)
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Verify that manufacturer has assigned UDI
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Verify that UK MMDA storage and transportation requirements are fulfilled
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Maintain a register of complaints as required by law
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Inform manufacturer if device provides serious risk/is not in conformity
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Check to ensure that devices have been registered with UK MHRA
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Report to MHRA regarding serious incidents or risks
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Cooperate with MHRA regarding preventative/corrective action
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Check identification of devices within the supply chain
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Get on Board Soon with UK Requirements
Register your company and devices with DORS as soon as possible to make sure you meet evolving MHRA requirements. 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.
See How MedEnvoy Can Help You Comply with New UK MHRA Requirements
As an independent medical device importer for companies exporting to the UK, it’s our job to help you maintain compliance with UK MHRA requirements. Feel free to contact us for any additional information!