UKCA – What does it mean for medical device companies?
This has been a big week in the entire medical device community’s understanding of the impact of Brexit on the medical device industry. On September 1 the UK government announced guidelines on the changes to how medical devices will be regulated in the UK as of January 1, 2021. This was closely followed by the second reading in the House of Lords, the upper house of the legislature, of the bill that will ultimately bring these changes in to UK law.
The key point is that the UK government’s existing regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), will take over responsibilities that are currently those of the European Union. In due course we will see products carrying the new United Kingdom Conformity Assessment (UKCA) mark instead of, or as well as, the well-known CE Mark.
But what does this mean for medical device and health tech companies?
Let’s answer that by splitting the companies in to three groups:
UK-based companies supplying to the UK
Non-UK-based companies supplying into the UK, including those based in the EU
UK-based companies supplying to the EU
After that, we’ll consider important details in the changeover between the EU-based and the new UK regulations.
For UK-based companies intending to supply initially, or only, into the UK there will be very little change for the time being:
Up until June 30, 2023
CE marking will continue to be used and recognised
Certificates issued by existing Notified Bodies will continue to be valid in the Great Britain (GB) market
The key addition is that companies will need to register themselves and their products with the MHRA before the products are placed on the GB market
Currently registration is not expensive – at the time of writing it is 100 GBP to register a new or changed device on the database – it’s not clear if this price will remain the same.
From July 1, 2023
It will be mandatory to place the UKCA Mark (see below) on products being supplied into the GB market – from January 1, 2021 this will be an option instead of, or as well as, the CE Mark
However, CE marking will still be required for products being supplied to Northern Ireland (NI) market – the UKCA Mark will not apply there
For non-UK-based companies intending to supply into the UK, the above points will apply but in addition, as from January 1, 2021, these companies will have to appoint a UK Responsible Person (UKRP). The UKRP – which by the way can, and should, be a company (a ‘legal person’) not necessarily an individual (‘natural person’) – has obligations broadly similar to those of the Authorised Representative (AR) already required by the EU medical device regulations. The UKRP must be based in the UK, similarly to how an EU AR must be based in a member state of the EU.
UK-based companies intending to supply to the EU must continue to do what they do now, but appoint an EU AR per the EU regulations, in addition to any UKRP. GB-based ARs will no longer be allowed: ARs need to be in the EU or in NI.
So what is the difference between what you have to do to place a CE Mark on a product versus a UKCA Mark?
There are two levels to this answer:
The mechanics of UKCA-marking
The regulatory basis for conformity assessment
The mechanics are that a UK Approved Body will need to perform the conformity assessments that formerly the EU Notified Body (NB) would do. It appears that the two UK-based NBs that are able to do the necessary for medical imaging products will become UK Approved Bodies automatically, so not much change there, except that they will need to authorise both a CE mark and (in due course) a UKCA mark (likely at an extra fee). It is not clear whether EU-based Notified Bodies will be allowed, and at what point in time, register as UK Approved Bodies.
Additionally, while the UK standards will be the same in substance and with the same reference as the standards used in the EU, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body. All references to standards in any regulatory documentation to be submitted for a UKCA assessment would therefore have to be updated with the ‘BS’ prefix.
Does having both a UKCA mark and a CE mark mean double the work (and double the cost)?
At the moment – fortunately – it looks like the answer is no. All we can say for now is what the draft post-Brexit UK regulation states – the Medical Devices (Amendments etc.) (EU Exit) regulations 2019, 2019 No. 791. This is a 234-page document – in which you’ll find on pages 27 to 80 what amounts to a clone of the EU Medical Device Regulation (MDR), and on pages 81 to 125 a clone of the EU In-vitro Diagnostic Medical Device Regulation (IVDR). So, from a UK perspective, the MDR and IVDR will still be replacing the respective Directives.
In conclusion, there are many more subtleties to discuss, but this article hopefully explains the key points, that:
A new UKCA mark is being introduced – which is mandatory from July 2023 but optional between January 2021 and June 2023 – applying to products being deployed to GB, not the UK as a whole
The actual work to be done by manufacturers under the new UK regulation is more-or-less the same as required under the EU MDR and IVDR, but will require different references to standards.
A simple administrative step, with a fee, of registration of devices with the MHRA will be required for a UK national database of approved devices
A more complex and urgent step is for manufacturers from outside of GB (not the whole UK, just GB) to appoint a UKRP, as well as, or instead of, their EU AR depending on whether or not they are deploying product to the EU
The most complex step is that if a manufacturer is using an EU, not UK, based Notified Body then they will need to additionally engage a UK Approved Body
Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
