What is a perspective timeline and cost for a Class I medical device registration in the UK?
This topic is coming up time and time again so far in 2026 from manufacturers wishing to enter the UK market, and the good news is that Class I is relatively accessible, but accessible does not mean straight forward.
For a Class I medical device which is non-sterile, with no measuring function, registration is self-declared, no Notified Body involvement is necessary, and the process is as follows:
- Prepare the UK Technical File and UK Declaration of Conformity (DoC); this mirrors the requirements of EU Medical Device Regulation (MDR) 2017/745 Annex II/III, but references UK regulation, specifically UK MDR 2020 as amended.
- Register with the MHRA’s Device Online Registration System (DORS), the registration fee is £100 for the initial device within a product family.
- The MHRA will then process the registration, this can typically take 2-4 weeks once the submission is complete and accurate.
The £100 fee associated with the DORS registration is somewhat misleading however; the true cost is in the preparation of the technical documentation, depending on the complexity of the device in question and how much of any preexisting technical documentation may be utilised and adapted for UK purposes, the cost of consultant or internal regulatory resource may add thousands of pounds for a straightforward Class I device.
NOTE: Class I sterile devices and Class I devices with a measuring function are a different category. These require Notified Body involvement and costs can rise significantly as well as timelines.
On a practical note, do not assume that the device classification from the EU translates directly to the UK; classification rules are very similar but not identical, and this should be double checked before committing to a registration pathway.
Does the indefinite recognition of the CE mark in the UK effectively render UKCA as an optional extra of European manufacturers?
In terms of market access to Great Britain, the answer is largely yes, for now. If the MHRA finalises the indefinite recognition of CE marked devices, the immediate regulatory pressure to obtain UKCA is substantially reduced for European manufacturers.
However, caution is advised to most manufacturers when treating UKCA as optional, there are a number of reasons to pursue certification regardless:
- Policy Reversal Risk: CE recognition has already been extended numerous times since Brexit, creating persistent planning uncertainty. Each extension has been announced with relatively little notice; an indefinite recognition policy could in theory be reversed or scoped differently under a future government. UKCA certification provides an amount of insulation from this risk and should not be overlooked.
- Procurement Requirements: Some National Health Service (NHS) trusts and public sector procurement frameworks are beginning to specify UKCA, especially regarding high-risk device categories; this is still an emerging trend but indicates a directional shift.
- Domestic Manufacturing: CE recognition under the MHRA framework applies to medical devices placed onto the British market which hold a CE mark; if your medical device is manufactured in the UK, the CE recognition route does not apply, UKCA is mandatory.
- Commercial Signaling: For manufacturers with a significant commercial presence in Britain, holding UKCA certification can provide a signal of regulatory intent to UK stakeholders.
At present, CE recognition renders UKCA optional but not irrelevant, for companies with a strategic interest in the UK market, a UKCA programme, even if not immediately required, should be planned for now rather than scrambling for it later.
How does the MHRA’s proposal to align with EU MDR timelines change manufacturers attitudes toward UKCA?
In short, the answer is that alignment with EU MDR timelines materially reduces the urgency and creates a strategic sequencing opportunity. If the MHRA aligns the legacy Medical Device Directive 93/42/EEC (MDD) certificate deadline with the EU’s extended MDR transition, which now extends to 2028 for the majority of devices, manufacturers can prioritise getting EU MDR right first, then use the resulting technical documentation as the basis for UKCA certification.
The above sequencing is logical for the following reasons:
- EU MDR compliance is the far heavier lift, the clinical evidence requirements, GSPR mapping, QMS alignment are all more demanding than the incremental work required to adapt that documentation for UKCA.
- Technical file repetition is exhausting, the UK MDR requirements are substantially derived from EU MDR, so an EU MDR compliant technical file requires relatively minor adaptation for UK purposes.
- Notified Body capacity is a finite resource, UK Approved Bodies have a limited bandwidth and manufacturers which defer UKCA work will face the same capacity issues that the EU market experience between 2023 and 2024.
NOTE: Treat EU MDR completion as the gate and build UKCA into the tail end of that programme rather than running a parallel workstream. Do not defer scoping UKCA indefinitely, Notified Body queues in the UK are already growing and a 2027 submission date may effectively require engagement in early 2026.
How should a manufacturer manage a single Stock Keeping Unit (SKU) which needs to satisfy both UKCA (GB) and EU MDR (Northern Ireland) without redundant labelling?
Northern Ireland’s (NI) dual access status, sitting within UK territory but aligned with EU single market rules for goods, creates a genuinely complicated labelling challenge for manufacturers with a single SKU sold across both GB and NI.
The approach which has been seen to work most reliably in practice is dual labelling on a single base label; the label carries both the UKCA mark for GB and the CE mark for NI and the EU, with a single UK Responsible Person (UKRP) and an EU Authorised Representative (AR) listed as appropriate; the MHRA have confirmed that this dual mark approach is permissible.
For manufacturers seeking a perhaps more elegant solution, a base label with market specific overlay or peel away sections can work, but adds to supply chain and quality management complexities, particularly around label revision control and ensuring that the correct label variant reaches the correct market as intended.
In terms of technical documentation, the most efficient approach is a single technical file structured to demonstrate conformity with both E...
