If you’ve got a medical device with some history behind it, perhaps a technical file written under the old directives or documentation inherited from a previous consultant, you’ve probably wondered how much of it would stand up against the current requirements. A UKCA gap assessment, or an MDR one (in practice it’s often both at once), is the piece of work that answers that question. With UK regulation where it is in 2026, it’s worth understanding what one involves before you commission it, so here’s how we approach it at MDIN.
What a gap assessment actually is
A gap assessment is a structured comparison between the documentation you have and the requirements of the regulation you’re aiming to meet, whether that’s the EU MDR, the UK regime, or both. The output is a report that works through the requirements, states whether your existing evidence meets each of them, and sets out what’s missing or needs updating. It isn’t an audit, and it doesn’t produce a certificate. Nobody can approve a device off the back of one (conformity assessment is the job of a notified body or approved body, depending on your route and class), so we present the report for what it is: a map of the work remaining, not any kind of approval.
The real value is in the prioritisation. Most files we look at have gaps somewhere, and a long undifferentiated list of findings isn’t much use to anyone. What you actually want to know is which items are genuine blockers to approval and which are things an assessor might comment on but you can deal with in the normal course of the work. A good gap report separates those clearly so the plan can be built around getting the device to market.
Where the gaps usually turn up
Every file is different, but after a reasonable number of these there are places I now look first.
Technical files structured around the old essential requirements rather than the general safety and performance requirements are still common. The mapping between the two is close enough that people assume it’ll pass, which it generally won’t without being reworked. If you want a fuller picture of what the current expectations look like, I’ve written separately about what actually goes in a medical device technical file.
Clinical evaluations are probably the most frequent serious finding. Equivalence arguments that rely on data the manufacturer doesn’t actually have access to come up regularly, as do literature searches that haven’t been repeated since the original submission, and this is an area where assessors have become noticeably stricter.
Risk management files often reference withdrawn versions of ISO 14971. More importantly, they still tend to carry ALARP thinking (risks reduced as low as reasonably practicable, with cost allowed as a factor), whereas the MDR requires risks to be reduced as far as possible without adversely affecting the benefit-risk ratio. The documents usually exist, so this is more a case of restructuring than starting again, but it takes time.
Post-market surveillance catches people out even on devices that have been selling happily for years. The GB requirements were strengthened in June 2025 and now expect a proper PMS plan with defined data collection and reporting on a set schedule. A device that was compliant when it was placed on the market isn’t necessarily compliant in how it’s being monitored today.
Most of the rest sits in labelling and UDI readiness, and in the links between the quality system and the technical file (design change records especially). Individually these are rarely blockers, but together they can add up to quite a bit of work.
Why the timing matters in 2026
The UK position is the reason to think about this now rather than leaving it for next year. As things stand, CE marked devices are accepted in Great Britain until 30 June 2028 for devices certified under the old directives and 30 June 2030 for devices certified under the EU MDR. The MHRA ran a consultation earlier this year on recognising CE marking indefinitely, which closed on 10 April 2026, and as I write this no outcome has been published, so those dates remain the ones to plan against.
At the same time, the MHRA published draft new GB regulations in the spring covering international reliance, reclassification of some device types, UDI and implant cards, and the general expectation is that these will be made in the coming months with transitional periods to follow. So the requirements are moving, but none of this is a reason to wait. Whatever the MHRA decides on CE recognition, the documentation standard you’re being measured against is the current MDR one, and a file that meets it serves you on either route. If you’re still weighing up which market to lead with, I’ve set out the trade-offs in UKCA vs CE marking in 2026: which do you need first?
When you actually need a UKCA gap assessment
There’s no rule that says you must have a gap assessment, so it’s worth being clear about when one is worth doing. These are the situations where I’d recommend one:
- You have a legacy device certified under the MDD and you’re heading into MDR conformity assessment, where the gap between what you have and what’s expected is usually wider than people hope.
- You’ve acquired a product, or taken over documentation from a previous consultant or a team member who’s moved on, and nobody currently in the business can say with confidence what state the file is in.
- Your device has changed significantly since the file was written (materials, suppliers, intended purpose, manufacturing process) and the documentation hasn’t kept pace.
- You’re a UK developer approaching your first submission, perhaps at the end of a grant-funded project, and you want to know how far your existing design history actually gets you before you engage an approved body.
- Your device has been on the GB market for a while and you haven’t revisited your PMS arrangements since the June 2025 changes.
If your device is still at concept stage there isn’t much documentation to assess yet. The more useful exercise then is a shorter look at classification and regulatory route, followed by building the documentation properly alongside the design work, which is how we run development projects.
What you get at the end
Our gap assessment service produces a written report: a gap map against the MDR and UKCA requirements, with each finding marked as must-do or can-wait and given a rough effort and time. That feeds a roadmap for the following 6 to 12 weeks, showing what has to be closed before submission and what can run in parallel. Because we do the design and bench testing in-house near Bristol, we can also pick up the remediation work where that’s wanted, whether that’s rewriting sections of the file or running bench tests to fill evidence gaps, rather than handing you a list of problems and wishing you luck.
If you’re weighing up whether your documentation is ready for MDR or UKCA conformity assessment, I’m happy to talk it through on a call, with no obligation on either side. You can book a free 30 minute call here.
Frequently asked questions
No. An audit checks conformity against a standard or QMS requirement and is often a formal event with findings you must respond to. A gap assessment is a planning tool with no formal status. Its purpose is to show you the size and shape of the work remaining before you put the device in front of an assessor.
If the certificate is under the EU MDR and the file is current, possibly not. If it’s a directive-era certificate, or the device or its documentation has drifted since certification, then yes. GB acceptance of directive-certified devices currently runs to 30 June 2028, and closing the gap takes longer than people expect.
No, and you should be wary of anyone who says they can. Certification is carried out by notified bodies (CE) and approved bodies (UKCA). We develop devices and prepare their documentation for conformity assessment, which is a different job.
The consultation on that closed in April 2026 and no outcome has been published as I write this. If indefinite recognition does come in, a solid MDR-compliant file becomes even more clearly the thing to have, so the gap assessment work isn’t wasted either way.
It depends on the class of the device and how much documentation there is. For a single device with a reasonably complete file it’s a contained piece of work measured in weeks rather than months, and we’ll scope it with you before starting.