Navigating the UK Medical Device Regulatory Landscape in 2026

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:

1. 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.
2. Register with the MHRA’s Device Online Registration System (DORS), the registration fee is £100 for the initial device within a product family.
3. 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 EU MDR Annex I GSPRs and their UK equivalent. In practice, because the UK requirements are so similar to EU MDR, the technical content is almost identical. The key differentiating factor is in having two separate Declarations of Conformity, one which references UK regulation and one referencing EU MDR and ensuring your QMS is audited to cover both markets.

NOTE: The NI situation is one where a labelling review is strongly recommended before products reach the stage of distribution. The dual mark approach is well established, however the details on implementation need to be correct from the outset to prevent recalls or enforcement action.

How “automatic” is the MHRA Reliance Route in practice? Will a 510(k) clearance really allow for faster UK registration?

The Reliance Route is one of the most misunderstood aspects of the current UK regulatory landscape and it is key to managing expectations.

In essence, it is not automatic, the name implies a degree of passthrough that does not affect the operational reality. What the Reliance Route does in reality is allow the MHRA to utilise a prior approval from a trusted regulator (US FDA, Health Canada, Australia’s TGA) as a significant input into its own assessment, rather than conducting a fully independent review from scratch.

Regardless of 510(k) status, manufacturers will still need:

• A complete UK technical file meeting UK MDR requirements
• UKRP appointed and registered in DORS
• UK DoC (Declaration of Conformity)
• Full DORS registration with applicable fee paid

The Reliance Route in actuality delivers a reduced MHRA review time; current experience in the industry suggests that current time reductions are around 3-6 months compared to a standalone UK submission. For Class IIb or III devices where a conventional pathway could take as long as 18 months, this represent a significant reduction in time but is not the same as automatic recognition.

It should also be noted that the quality of the 510(k) matters, MHRA will consider the scope and substance of the FDA’s review. A broad 510(k) with limited clinical data review will carry reduced weight than a PMA or a 510(k) which included significant FDA engagement on clinical evidence.

Which device classifications or technologies are likely to be excluded from the Reliance Route and will still require full UK Approved Body assessment?

The Reliance Route is not universally available, and there are categories where the MHRA has signalled that it will expect full UK Approved Body involvement regardless of prior foreign approvals.

The most distinct exclusion category is high risk implantable devices; Class III devices with permanent or long-term body contact, particularly novel materials or mechanisms are an area where the MHRA wants independent assessment.

The next category is regarding novel Software as a Medical Device (SaMD), particularly Artificial Intelligence (AI) and Machine Learning (ML) or therapeutic software. The MHRA has been actively developing its position in this regard and has indicated a preference for full review in these cases. The pace of change in this space means the MHRA does not want to simply defer to another regulator’s assessment that may be based on different or outdated guidance.

Beyond this, the general principle applied is, the higher the risk class, the more novel the technology and the less established the clinical evidence base, the less likely the MHRA is to rely on foreign approval without independent assessment. Additionally, devices with post-market safety signals, even when approved elsewhere, may be subject to a full review regardless of their classification.

NOTE: Make no assumptions regarding the Reliance Route eligibility without a pre-submission discussion with the MHRA or with a consultant that has significant experience of MHRA’s operational approach. The published framework is helpful but does not capture all the nuance of how assessments are conducted in practice.

Does the MHRA require a UK specific Software Bill of Materials (SBOM) format, or are they harmonising with FDA cybersecurity documentation standards?

The MHRA has not mandated a UK specific SBOM format, and its current direction is clearly toward harmonisation with international standards rather than creating a UK specific documentation framework.

The applicable standard referenced by MHRA in terms of cybersecurity is IEC 81001-1-1, which is an internationally harmonised standard covering health software and health IT systems. This standard is aligned with, and somewhat derived from, the broader IEC 62443 industrial cybersecurity framework and it not UK-specific.

Specifically regarding SBOMs, the MHRA’s approach is consistent with the FDA’s 2023 cybersecurity guidance, which established SBOM as a mandatory component of pre-market submissions for cyber devices. A well-constructed SBOM which satisfies FDA requirements, covering commercial, open source, and off the shelf software components, with version information and known vulnerability status, will typically satisfy MHRA review without significant modification.

However, there are important nuances, the MHRA has explicitly reserved the right to issue UK specific cybersecurity requirements as the SaMD and AI/ML landscape develops, the current harmonisation situation should not be assumed to be permanent or guaranteed. Manufacturers of cyber enabled devices should monitor MHRA guidance actively, it is recommended to build cybersecurity documentation in a modular way which can be updated without requiring full technical file revision.

NOTE: Manufacturers who are dual filing with FDA and the MHRA, a single SBOM prepared to FDA standards, including any UK specific labelling or documentation references is currently the most efficient approach.

What are the immediate consequences for a manufacturer in their UKRP missed the March 30th, 2026, DORS account update deadline?

This question is very timely, UKRPs who are uncertain about their compliance status are currently very actively addressing the situation.

For clarity, former ARs acting as UKRPs were required to update their DORS accounts to the new UKRP format by March 30th, 2026, which in essence is an administrative update but it has substantial consequences if missed.

The immediate legal consequence of is that the manufacturer registrations on the DORS system become noncompliant; devices whose UKRP registration is not in good standing, are not lawfully placed onto the GB market from that point forward.

In real terms, the MHRA has enforcement discretion and had historically applied a proportionate approach to administrative compliance failures, particularly where there is no patient safety issue and the manufacturer can show good faith. For a straightforward administrative update that was missed, a corrective action notice and a remediation window is the most likely initial response rather than immediate withdrawal action.

However, discretion is not guaranteed, and relying on it does not constitute a compliance strategy, immediate recommendations for manufacturers in this situation:

• Immediately contact your UKRP to confirm whether the account update has been completed prior to March 30th.
• If the update has not been completed, the UKRP should be engaged to complete it as a matter of urgency, the longer the gap, the more difficult the conversation with the MHRA becomes.
• If there is any doubt regarding the UKRP’s compliance, also consider if this is a good time to review your UKRP arrangement more broadly, given the upcoming liability changes discussed in the next question.
• If the MHRA contact is necessary, approach it proactively rather than reactively, a voluntary disclosure of an administrative error, accompanied by a remediation plan, is always received better than a response to an enforcement inquiry.

How is the prospect of “joint and several” UKRP liability changing the cost and selectivity of third-party UKRP services?

This is one of the most significant structural shifts in the UK regulatory services market and it is already having a notable impact even before liability framework is formally confirmed.

The proposed alignment with the EU AR liability model, under which the UKRP could be held jointly and severally liable for defective devices, alongside the manufacturer, fundamentally alters the risk calculus for third-party UKRP providers. Under the current framework, the UKRP role carries primarily administrative and regulatory compliance obligations; under the proposed framework, it carries financial and legal exposure for device defects.

There have been three clear effects in the market already as a result:

1. Rigorous Due Diligence: UKRP providers are conducting more rigorous due diligence on prospective clients before accepting appointments; this includes review of technical files, QMS audit status, post-market surveillance plans and complaint histories. The era of a UKRP accepting a client based on a short-term self-declaration is ending.
2. Increased Costs: The risk premium associated with joint and several liability is being priced into service agreements. UKRP fees, particularly for higher risk device classes, are increasing materially. For Class III or implantable devices, some providers are moving toward annual retainer models that more closely resemble the cost structure of EU AR services.
3. Market Consolidation: Some established UKRP providers are actively reviewing their existing client portfolios and declining to renew arrangements with manufacturers whose risk profiles they are no longer comfortable with. This is creating a market access problem for some smaller manufacturers who may find it difficult to secure a UKRP at any price.

NOTE: Manufacturers who currently have an agreement with a third party UKRP and have not yet had a conversation with them since the liability proposals emerged, it is recommended to initiate this conversation promptly. Understanding the UKRP’s position prior to the renewal date of the agreement with them rather than discovering at short notice, gives added time to manage any transition.