Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and when they must appear on our products and packaging. Here's what medical device developers need to know about transitioning from the EU CE marking to the UKCA.
We asked medical device consultant Samantha Shelley for a quick overview of the likely timeline and challenges medical device developers will face as they prepare to transition to the UKCA marking.
This is what she said when we met her at Cognicon24 last month.
With this expert overview in mind, here's a bit more background and detail about the UKCA marking and how your company should prepare to meet the new UK regulation for medical devices (when it is finally released).
The UKCA (UK Conformity Assessed) marking is a certification mark that indicates products, including medical devices, conform to UK regulatory requirements and standards.
Following Brexit, this marking was intended to replace the CE Marking (which signalled conformity with EU regulations) to indicate a product could legally be sold in the UK.
However, since the UK voted to leave the European Union, this goal has been subject to delays and backtracking for some sectors.
Several product types have been indefinitely exempted from the UKCA marking requirement, but not medical devices.
But it's worth noting that Northern Ireland will continue to use the CE marking permanently for all products sold there as part of the Northern Ireland Protocol!
Yes.
Officials have set up all the mechanisms for the UKCA marking to be the official conformity requirement for medical devices in the UK.
There is a process to register your product with the MHRA, and the government has appointed UK-approved bodies to which developers can apply for their conformity assessment.
While it is possible to apply for a UKCA marking for your medical device, there has been a severe shortage of UK-approved bodies to handle expected demand. Additionally, the future of the UK's post-Brexit regulation has not been finalised. As a result, the deadlines for transitioning to the UKCA marking have been repeatedly pushed back.
Because of this, many developers have decided to 'wait and see' what the new regulation will demand before they go through the CA process with the required bodies.
Right now, developers who want to sell their medical devices in the UK must adhere to the regulations set out in the Medical Devices Regulations 2002 (as amended).
Ironically, these are based on old EU directives:
But significant changes are planned.
The UK government's website contains lots of information about the consultation process and the potential shape of future medical device and IVDR regulation.
Politicians hope the ability to determine our legislative future will give a new kind of freedom and flexibility for UK developers to compete internationally. As the Chancellor said in the 2023 budget statement:
All the indications are the regulations will align very strongly with other international conformity frameworks.
In fact, in our interview with Sam Shelley, she anticipated that the new regulation would look very similar to the EU MDR:
The MHRA road map anticipates that new, UK-specific regulation will become law by mid-2025 (but depending on the outcome of the general election in July 2024, this may be subject to change).
While the UKCA marking for medical devices came into force in 2021, it will not be mandatory in the UK until at least July 2025.
Until then, medical devices can be marked with EITHER the CE or the UKCA marking (or both) to be legally traded in the UK.
After that, the government has announced extended transition periods for different devices.
But in summary, the MHRA will continue to recognise the European CE Marking until 2028 or 2030, depending on the type of device you are marketing.
For more details, you should consult the MHRA website.
In spite of the announced extension periods and new potential delays following the general election, medical device developers still need to be on their toes and planning to make the transition.
As mentioned above, the MHRA have designated 'UK Approved Bodies' to oversee and ensure the compliance of medical devices and products within the UK market.
These bodies are equivalent to the EU Notified Bodies that ensure conformity with EU law.
The route to working with these bodies and the MHRA to approve your product for sale in the UK is already well mapped out, even though the new regulation has not been finalised.
Some companies are still opting for apply for the UKCA marking .
Before placing a medical device on the UK market, manufacturers (or their authorised representative) must register with the Medicines and Healthcare products’ Regulatory Agency (MHRA).
If the manufacturer is not based in the UK, they must appoint a UK-based representative AKA the ‘UK Responsible Person’.
Depending on the classification of their medical device, manufacturers will need to choose an appropriate Conformity Assessment route. Some devices can be self-certified, but others will need a more rigorous assessment based on their classification and risk profile. Information on UK classification system can be found the the UK government’s website.
For certain classes of medical devices, the manufacturers will need to select a UK Approved Body to work with. This body will evaluate the device to ensure it meets regulatory requirements.
Manufacturers will need to prepare the technical documentation that provides evidence of conformity with the relevant legislation. The UK Approved Body will review this documentation.
The UK Approved Body will conduct a conformity assessment, which may include inspecting the manufacturing site, reviewing technical documentation, and testing the device.
Once the device has been assessed and deemed to meet all requirements, the manufacturer will need to draw up a UK Declaration of Conformity. This is a formal statement that the device complies with the relevant regulations.
After the declaration of conformity is complete, the manufacturer can affix the UKCA mark to the device. The marking must be visible, legible, and indelible.
Even after obtaining the UKCA mark, be aware manufacturers will have ongoing responsibilities to be answerable to the MHRA, including monitoring the performance of the device in the market and reporting any adverse events. There are new PMS requirements from the MHRA that developers should take note of.
Depending on the device and the chosen conformity assessment route, manufacturers may need to undergo periodic reviews or renewals with their UK Approved Body.
Following Brexit, medical device developers will undoubtedly face additional complexities as they prepare to sell their devices in the UK and EU. After all, there are now two separate regulatory regimes with which to comply.
But, at least the UK looks like it will align with the EU MDR and the FDA, which has already announced closer alignment with ISO 13485:2016.
If you already have approval to affix a CE marking and have gained the ISO 13485 standard - it should be relatively straightforward to assemble the required documentation and manage the UKCA process.
But smart device developers should follow the news and work closely with consultants to ensure they have the best advice and digital tools in place to pass their Conformity Assessment at the right time for them.
Last updated on 19/06/2023