If you’re developing a medical device in the UK at the moment, one of the first regulatory questions you’ll run into is whether to aim for UKCA marking, CE marking, or both, and in which order. It’s a question I get asked quite a bit, usually early on when a team is trying to plan their budget and timeline, and the honest answer is that it depends on where you want to sell first. That said, the picture in 2026 is clearer than it was a couple of years ago, so I thought it was worth setting out how I’d think it through, along with where the MHRA currently stands on accepting CE marked devices.
A quick note before we start: the deadlines and proposals below are correct as I write this in August 2026, but this is an area that moves, so do check the current MHRA guidance (or ask us) before making decisions off the back of it.
Where CE marking stands in Great Britain right now
The starting point is that CE marked devices are still accepted on the Great Britain market, and will be for a while yet. Under the current transitional arrangements, a device certified under the old EU directives (MDD or AIMDD) can be placed on the GB market until its certificate expires or 30 June 2028, whichever comes first, and a device compliant with the EU MDR or IVDR can be placed on the GB market until 30 June 2030.
In practice this means that if you CE mark your device, you can sell it in England, Scotland and Wales without a UKCA mark, provided you register it with the MHRA first. Registration is required for all devices on the GB market regardless of which mark they carry, and it’s a reasonably straightforward process, but it does need doing before you place anything on the market.
Northern Ireland is different, and it catches people out. NI follows the EU regulations, so a device sold there needs a CE mark, full stop. If the UK as a whole is part of your plan, that alone pulls CE marking into the conversation.
The MHRA consultation on indefinite CE recognition
The bigger development this year is that the MHRA ran a targeted consultation (it opened in March 2026 and closed in April) on whether CE marked devices certified under the EU MDR or IVDR should be accepted on the GB market indefinitely, rather than the recognition ending in 2030. The consultation also floated a streamlined route for devices that sit in a higher risk class under UK rules than under EU rules, and a possible six month extension for directive-certified devices, which would move that 2028 deadline to the end of 2028.
At the time of writing there’s no published outcome, and the expectation is that we’ll hear more later this year. My view is that some form of continued CE recognition looks likely given the direction of travel, but I wouldn’t build a business plan on a consultation outcome that hasn’t been announced. What I’d take from it is simpler: CE marking is not about to stop working in Great Britain, and for most devices the EU MDR route gives you the longest runway on both sides of the Channel.
When CE marking first makes sense
For most of the early-stage companies we work with, CE marking first is the sensible default, for a few reasons.
The first is market size. If you have any intention of selling into the EU, you’ll need a CE mark anyway, and the EU market is considerably larger than the UK alone. A CE marked device currently gets you the EU, Northern Ireland and (until at least 2030 for MDR devices) Great Britain as well, which is quite a lot of coverage from one conformity assessment.
The second is that the underlying work overlaps heavily. The design controls, risk management, verification and validation testing and clinical evaluation that sit behind a CE mark are largely the same evidence you’d need for UKCA, because the current UK regulations are still based on the old EU directives. If you build your technical file properly once, adapting it for the other market is a manageable exercise rather than a fresh start. I’ve written separately about what actually goes in a technical file, and almost all of it serves both routes.
The third is notified body versus approved body capacity. Neither is quick, but if you need third party assessment, the EU notified body network is larger than the UK approved body pool, and if you’re going to queue, you may as well queue for the mark that opens more doors.
When UKCA first is the right move
There are cases where I’d say UKCA first, or UKCA only, is the better call.
The clearest one is a Class I device (non-sterile, without a measuring function) aimed at the UK market. These can be self-certified against UKCA by the manufacturer, meaning no approved body is involved, and the route to market is as fast as your ability to do the work properly. The catch, and it’s a big one, is that self-certification doesn’t mean less documentation. You still need a full technical file, a risk management file to ISO 14971, evidence against the relevant standards and a declaration of conformity, and since 16 June 2025 the strengthened UK post-market surveillance requirements apply to devices on the GB market too, so the obligations continue well after launch. Self-certified is not the same as self-exempted, as such it needs treating with the same discipline as any other route.
The other case is a genuinely UK-focused product, something built around NHS procurement for instance, where EU sales are a distant maybe. There, UKCA keeps you away from EU MDR notified body costs and timescales entirely, at least for now, and you can revisit CE marking later once there’s revenue behind you.
Doing the work once
Whichever order you choose, the practical advice is the same: structure your development so the evidence works for both markets. That means mapping your design outputs against both the UK requirements and the EU MDR general safety and performance requirements as you go, rather than retrofitting one to the other later. In my experience the retrofit is where the real cost hides, because you end up repeating verification testing or rewriting documentation that was nearly, but not quite, right for the second market.
This is something we do as standard on development projects, building the technical file alongside the design rather than after it, and it’s also where an MDR/UKCA gap assessment earns its keep if you already have a device and documentation and want to know how far off either mark you are. For teams right at the start, the regulatory route is worth pinning down before the design gets ahead of it. We did exactly that on the HelloCath early-stage concept work, where agreeing the likely route early shaped what the first prototypes needed to demonstrate.
My view, in short
If you’re asking “which do I need first?”, I’d say it comes down to three questions. Where’s your first revenue coming from? If the answer includes the EU or Northern Ireland, CE first. Is your device Class I self-certifiable and UK-focused? UKCA first, and you can be on the market quickly if the file is done properly. Is your device higher risk and UK-only for now? That’s the genuinely finely balanced case, and I’d want to look at the specifics (and at where the MHRA lands on CE recognition) before calling it.
The one thing I’d steer everyone away from is treating this as a decision you can defer indefinitely. The regulatory route shapes your testing plan, your documentation and your budget, and the earlier it’s settled, the less time/effort gets wasted. If you’ve recently had grant funding and you’re working out how regulatory fits into your plan, I’ve covered that in what happens after an Innovate UK or NIHR i4i grant.
If you’re weighing this up for your own device, I’d be happy to have a call, no charge and no obligation, to talk through which route fits what you’re building. You can get in touch here.
Frequently asked questions
In Great Britain, yes. Devices certified under the old EU directives are accepted until certificate expiry or 30 June 2028, and EU MDR or IVDR compliant devices until 30 June 2030, provided the device is registered with the MHRA. Northern Ireland follows EU rules, so CE marking is required there in any case.
Possibly. The MHRA consulted in early 2026 on recognising EU MDR and IVDR certified devices indefinitely, but no outcome has been published as I write this. I’d treat continued recognition as likely but not guaranteed, and I wouldn’t base a long-term plan on it until it’s confirmed.
Yes. All devices placed on the Great Britain market must be registered with the MHRA before sale, whichever mark they carry.
For Class I devices (non-sterile, no measuring function) it can be much quicker, because no approved body is involved. The documentation requirements are essentially the same though, so the time saving comes from avoiding the third party queue, not from doing less work.
Largely, yes. The evidence base (design controls, risk management, testing, clinical evaluation) overlaps heavily, and if you structure the file against both sets of requirements from the start, maintaining both marks is a manageable overhead rather than a duplicate effort.