In this article Medilink Midlands’ Head of Connectivity Chris Dyke shares his thoughts on the Implementation of the Future Regulations.
In viewing this new document (9 Jan 2024) the first part of Implementation of the Future Regulations provides additional clarity to what has been previously announced i.e. ‘Transitional Arrangements’ and ‘Post Market Surveillance requirements’ but sets out very clearly what is acceptable and what is required for these areas which is very welcome. Together with additional confirmation the Certified CE products can still be procured and used up to 2028 / 2030 depending on the function and type and for those that have not moved over to MDR certification there is a stay of execution if they still have a certified MDD device.
The interesting parts come in ‘Future Core Regulations’ that all device manufactures must review. The ones that caught my eye:
- ‘Devices have a unique device identifier (UDI)’ – this is something we have highlighted for some time and all products being sold to the NHS should have had since 2020 or possibly before. See:
https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/chapter-4-registration-and-udi
We understand from companies there has been problems with registering products on EUDAMED – if you are experiencing problems then speak to one of Regulatory Affairs Members
Also look at GS1 coding GS1 UK | GS1 standards in healthcare - ‘New requirements for exempt in-house manufactured devices and custom-made devices’. Anyone with a class 1 device will need to pay close attention to this. Especially with regards to new CE and MDR classifications where products are now in scope or have changed levels.
- ‘Include new requirements for clinical investigations.’ This will potentially open up requirements for companies to do additional or update their clinical studies and RWE work. It also aligns with the governments look at speeding up clinical trials in the UK announced last November (https://healthmedia.blog.gov.uk/2023/11/22/what-were-doing-to-speed-up-clinical-trials-in-the-uk/) Which should also generate extra opportunities and work for our clinical research centres in line with the predecessor report by Lord O’Shaughnessy https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report
- ‘Introduce a framework for international recognition, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.’
My understanding of this is that if a company has another valid and recognised certification such as FDA certification then this will allow easier entry to the UK market. Although we have heard that there may be a need to verify clinical evidence and / or undertake a study / review in how the Medtech product would fit into a UK clinical healthcare setting. This would be very key within and digital products.
- Anyone involved in Marketing will need to pay attention to this ‘new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose.’ This will no doubt align with a products clinical trials / evaluation, hence if you don’t have evidence then you cannot make the claim. All part of what has always been the case, but we think that due to the opening up to other certification systems it appears to need strengthening here to cover any potential gaps.
- This is a growing area and is an obvious inclusion for future regulations ‘Cybersecurity requirements for software as a medical device including for artificial intelligence.’
- Finally ‘Clarify the requirements for economic operators; manufacturers, importers and distributors, and introduce a requirement to have a Person Qualified in Regulatory Compliance.’ Hence anyone that is involved with this area of work may need to tighten up on their contracts and ensure they have access to technical files and as above have a robust system in place for Post Market Surveillance activities related to their activities
The last part indicates that the MHRA will working with Industry and Trad associations and the Medtech sector on the implementation and adoption of the changes to the regulations.
In all none of this is new or different to what we have seen or heard previously other than looking at new ways of accepting recognised non CE / UKCA certificated products for sale here in the UK and confirmation of extending the deadlines for CE certified products. But does give a clear indication of the direction of thought (Roadmap) and hence where industry should be looking to put things in place or bolster their systems and process, they have to facilitate these changes.
Reference material
- Implementation of the Future Regulations – Updated 9 January 2024
Implementation of the Future Regulations – GOV.UK (www.gov.uk) - Roadmap towards the future regulatory framework for medical devices
PowerPoint Presentation (publishing.service.gov.uk) - Transition periods – Gantt Chart
Transition periods under new UK SI (publishing.service.gov.uk) - MTI News
MHRA outlines roadmap for new UK medical device regulations – Med-Tech Innovation (med-technews.com)
