Starting out

You don't know if your product is a medical device, and that uncertainty has a legal price

Selling an unregistered medical device in the UK carries an unlimited fine and criminal prosecution. For software products especially, the line between regulated and unregulated is genuinely contested, and the wrong call blocks NHS procurement entirely.

steps: 7; steps
to start: 2 to 3 days; to start

The short answer

Start with intended purpose: the words you use to describe what the product does decide whether it is a medical device and which class. Write that statement carefully, classify under both UK and EU rules, register with the MHRA before placing it on the GB market, and plan approved body time early if you are above class I. Private buyers increasingly ask for this before they will sign.

7 steps

Do it yourself: step by step

0 of 7 done

One paragraph: what the product does, for whom, in what setting, and what clinical decision it informs. Check it matches your website, deck and sales language.
Time
2 to 3 days
Typical cost
Free
Who does it
Founder and clinical lead
Done when: One approved statement used everywhere.
GB: UKCA, or CE marking. The government confirmed long-term GB recognition of CE marking on 21 October 2026; until the regulations are made, CE is accepted until 30 June 2028 (MDD, AIMDD) or 30 June 2030 (IVDD, EU MDR, EU IVDR). Northern Ireland: CE (plus UKNI if a UK notified body assessed it). Most class I devices can self-declare; higher classes need a UK approved body or EU notified body.
Time
1 week to decide
Typical cost
Free
Who does it
Founder
Done when: Route and timeline written in your regulatory plan.
Implement a quality management system to ISO 13485, plus risk management (ISO 14971), software lifecycle (IEC 62304), usability, clinical evaluation and post-market surveillance plans.
Time
6 to 18 months
Typical cost
£20,000 to £150,000+ depending on class and help needed (Solvable estimate)
Who does it
Quality and regulatory lead
Done when: Technical file complete and internally audited.

This problem is Solvable.

Copy this template

Regulatory pathway decision sheet

Free to copy, adapt and use. No sign-up.

Template

Regulatory pathway for [Product name], [date]

Intended purpose statement [Product name] is intended to [action] for [patient group] by [user type] in [setting] to support [clinical decision].

Is it a medical device? [Yes / No] Reasoning: [which function makes it a device or why it does not]

Classification

Market	Regulation	Class	Rule applied	Approved or notified body needed?
Great Britain	UK MDR 2002	[ ]	[ ]	[ ]
Northern Ireland	EU MDR	[ ]	[ ]	[ ]
EU	EU MDR	[ ]	[ ]	[ ]

Marking route: [UKCA / CE (long-term GB recognition confirmed 21 October 2026; check current MHRA dates) / both]

Plan

Workstream	Standard	Owner	Start	Finish	Budget
Quality management system	ISO 13485	[ ]	[ ]	[ ]	£[ ]
Risk management	ISO 14971	[ ]	[ ]	[ ]	£[ ]
Software lifecycle	IEC 62304	[ ]	[ ]	[ ]	£[ ]
Usability	IEC 62366-1	[ ]	[ ]	[ ]	£[ ]
Clinical evaluation	[ ]	[ ]	[ ]	[ ]	£[ ]
Post-market surveillance plan	[ ]	[ ]	[ ]	[ ]	£[ ]
Approved body assessment	[ ]	[ ]	[ ]	[ ]	£[ ]
MHRA registration	[ ]	[ ]	[ ]	[ ]	£[ ]
UK Responsible Person (if non-UK manufacturer)	[ ]	[ ]	[ ]	[ ]	£[ ]

Sales and marketing check

Website, deck and proposals use only the intended purpose wording
No claims beyond the current class and evidence

Avoid these

Common mistakes

Marketing language that claims more than the intended purpose, which can change the class.
Assuming software is unregulated because it is an app or uses AI.
Classifying under UK rules only and then finding the EU class is higher.
Contacting an approved body after the technical file is finished, then waiting months for a slot.
Forgetting MHRA registration and a UK Responsible Person for non-UK manufacturers.

Free personal check

Done by Paul Robinson, not software

I'll read your intended purpose statement and give you a plain view of the regulatory route it points to

What I need from you

Your intended purpose statement or product description
Where you plan to sell: UK, EU or both

What you get

A plain view on whether your wording points to a medical device
The likely marking route and order of steps
The three changes that matter most

Within 2 working days

No sign-in, no sales call. I read every request myself and reply on WhatsApp.

Free tools

Check where you stand

Formula

Cost of an unclear pathway = months of delayed launch × expected monthly revenue + rework cost if reclassified late

Variables and defaults

months of delay: 9
expected monthly revenue once launched: £15,000
late rework cost: £40,000

Defaults only. Change them in the calculator to use your own numbers.

Assumptions and defaults

months of delay = 9
expected monthly revenue once launched = £15,000
late rework cost = £40,000

Solvable estimate. 9 × £15,000 = £135,000 plus £40,000 rework, about £175,000, range £100,000 to £250,000.

Benchmarks

On 21 October 2026 the government confirmed CE-marked medical devices and IVDs will be recognised in Great Britain on a long-term basis. The regulations are not yet made. Until then: MDD and AIMDD devices until 30 June 2028 (or certificate expiry); IVDD, EU MDR and EU IVDR devices until 30 June 2030
Check the current MHRA position before relying on CE marking alone
Source: GOV.UK and MHRA
First-time quality system and technical file for class IIa software typically costs £50,000 to £150,000 and takes 12 to 24 months including approved body review
Varies with in-house expertise and approved body capacity
Solvable estimate

The boundary between regulated medical devices and unregulated wellness or clinical decision support software is genuinely ambiguous for many healthtech products. Post-Brexit, UK and EU regulatory pathways have diverged, and the MHRA's Software as a Medical Device guidance has created new obligations for products that previously fell outside regulation.

The primary root causes stem from the inherent ambiguity in classifying novel healthtech products, particularly software, coupled with the divergence of UK and EU regulatory frameworks post-Brexit.
This is exacerbated by the MHRA's evolving guidance on Software as a Medical Device, which introduces new obligations for products previously considered unregulated.
Furthermore, a lack of internal regulatory expertise or reliance on consultants without deep SaMD-specific knowledge contributes to misclassification and non-compliance.

Selling an unregistered medical device in the UK carries an unlimited fine and criminal prosecution. UKCA marking for a Class IIa software device costs £30,000–£80,000 and takes 12–18 months. Regulatory non-compliance can also block NHS procurement. (MHRA, 2024)

Increased workload for regulatory and quality teams
Diversion of R&D resources to address compliance gaps
Significant fines and legal costs for non-compliance
Loss of revenue from delayed market entry or product withdrawal
Damage to brand trust and credibility
Negative publicity from enforcement actions or product issues

What it looks like in practice

Product development delays due to unclear regulatory pathways
Unexpected costs from re-classification or late engagement with Approved Bodies
Market access restrictions or product recalls due to non-compliance
Difficulty securing investment or partnerships without clear regulatory status.

Paul Robinson

14 years in UK private healthcare

I solve this one for healthcare companies

Want a hand? I'll look at your situation and tell you the three things I'd tackle first.

A few quick questions, about two minutes. I read every one myself and usually reply the same day.

No sales call unless you ask for one. Just a straight answer from me.

I reply personally, usually the same day.

Questions

Frequently asked questions

Is our clinical decision support software a medical device?

If it processes patient data to give an individual recommendation that informs diagnosis or treatment, it very likely is. Check MHRA guidance and get a written opinion.

Should we go UKCA or CE first?

If you sell in the EU too, CE first is often more efficient. On 21 October 2026 the government confirmed long-term GB recognition of CE marking, but the regulations are not yet made. If GB only, compare approved body availability and cost. Check the current MHRA position before deciding.

Do private providers check regulatory status?

Increasingly yes, through clinical governance and procurement questionnaires. A clear registration status shortens their checks.

Can we sell while waiting for certification?

Not as a medical device on the GB market. You may run research under the appropriate approvals, which is different from selling.

How long does class IIa take?

Commonly 12 to 24 months from a standing start, much of it quality system build and approved body review.

Last reviewed: 30 October 2026

Sources

GOV.UK and MHRA

The Solvable community

You're not the only one with this problem.

One problem solved every week, on WhatsApp.

Join the community

One message a week. No sales messages. Reply STOP any time.

The short answer

Do it yourself: step by step

1Write the intended purpose statement2 to 3 days · Free

2Decide if it is a medical device1 week · Free, or £1,500 to £5,000 for a regulatory consultant opinion (Solvable estimate)

3Classify under UK and EU rules1 to 2 weeks · Included in consultant fee

4Choose your marking route1 week to decide · Free

5Build the quality system and technical file6 to 18 months · £20,000 to £150,000+ depending on class and help needed (Solvable estimate)

6Book approved body assessment early if needed6 to 18 months to certificate · £20,000 to £80,000+ (Solvable estimate)

7Register with the MHRA and appoint a UK Responsible Person if needed2 to 6 weeks · Annual MHRA registration fee, charged per GMDN category since April 2026