PredicateIQ — UK Medical Device Regulatory Intelligence

Now in beta — limited access

Your clients expect weeks.
You can deliver tomorrow.

PredicateIQ runs the complete predicate landscape, MDR classification, equivalence assessment, and clinical evidence search in minutes — so you can spend your time on judgment, not research.

See it with a client concept → How it works

Know your regulatory
position before you build.

Before spending a penny on development, PredicateIQ answers your four regulatory questions — predicate landscape, UK/EU pathway, equivalence, clinical evidence — in under 5 minutes, not 4 weeks.

Run your device concept → See the report

Concept Intelligence Report

Wearable Cardiac Monitor — Flags

Active device — Class IIa under UK MDR 2002 Rule 9Approved Body involvement required. Self-declaration route not available. Timeline impact: 6–12 months minimum.

IEC 60601-1 electrical safety — 3–6 month critical pathActive implantable-adjacent device triggers full electrical safety and EMC testing suite.

UK/EU divergence — dual-track requiredClass IIa (UK MDR 2002) vs Class IIa (EU MDR 2017/745). Separate NB/AB engagement needed.

Strong predicate landscape: 8 PARD, 24 FDA 510(k)Zio Patch (iRhythm), CardioNet MCOT clearances available for predicate comparison.

Four questions stand between your device idea
and any serious development decision.

Every founder and every RA consultancy faces the same wall at concept stage. The information exists — it's just spread across incompatible databases, frameworks, and publication types, and takes weeks to assemble.

The four questions

Does a predicate device already exist in any database?

3–5 days · manual search across 4+ separate systems · £1k–£3k

What is my UK regulatory pathway and device class?

1–2 weeks · RA consultant classification review · £2k–£5k

Can I claim equivalence to an existing device?

2–3 weeks · clinical evaluator manual comparison · £3k–£7k

What clinical evidence and standards will apply?

1–2 weeks · manual literature and standards triage · £2k–£5k

Typical cost per question

Predicate landscape£1k–£3k

UK MDR pathway£2k–£5k

Equivalence assessment£3k–£7k

Clinical evidence£2k–£5k

Total per concept £8k–£20k

And that's before a single piece of hardware has been designed. Worse — a human expert handles one concept at a time. An incubator screening 20 applicants faces a wall no amount of hours can solve.

The cost of getting this wrong is not £20k — it's £15M+. One company spent six months preparing a 510(k) before FDA ruled their predicate was inappropriate. The result: a clinical trial adding a year and millions to their timeline. PredicateIQ catches this in the first report.

PredicateIQ is the Senior RA consultant's power tool — and the Founder's early warning system.

Describe your device in plain English. PredicateIQ runs four parallel research modules across MHRA PARD, EUDAMED, FDA 510(k), PubMed, ClinicalTrials.gov, and the UK/EU harmonised standards databases — and returns a structured Concept Intelligence Report in under 5 minutes.

22,424

PARD devices

25,000+

FDA 510(k)

13,441

GMDN terms

<5 min

Full report

vs. manual process PredicateIQ

Predicate landscape3–5 days → <2 min

UK MDR classification1–2 weeks → <2 min

Equivalence assessment2–3 weeks → <2 min

Clinical evidence1–2 weeks → <2 min

Module 01

Device Landscape Search

Semantic search across MHRA PARD (22,424 records with brand names), EUDAMED, and FDA 510(k). Surfaces predicate candidates with MAUDE adverse event profiles and full chain tracing.

All tiers

Module 02

UK Regulatory Pathway

All 22 UK MDR 2002 Schedule 1 rules encoded as a deterministic decision tree. Returns device class, Approved Body requirement, EU MDR divergence flag, and Northern Ireland bifurcation from 28 May 2026.

All tiers

Module 03

Harmonised Standards Mapper

Applicable UK and EU harmonised standards ranked by priority — testing vs. documentary, typical duration and cost per standard. Cross-referenced against the FDA Recognised Consensus Standards Database.

All tiers

Module 04

Clinical Evidence Density Map

PubMed, ClinicalTrials.gov, Cochrane Library, and NICE queried simultaneously. Returns evidence maturity score, active trial count, and identified literature gaps — the foundation of any CER or investor deck.

All tiers

Module 06

EU MDR Equivalence Workbench

Structured equivalence assessment under EU MDR Annex XIV and MEDDEV 2.7/1 Rev 4 — clinical, technical, and biological dimensions. Auto-flags third-party device access requirements.

Studio · Accelerator

Module 07

Predicate File & CER Workflow Engine

10-phase engine covering the complete Senior RA consultant process — predicate file, CER draft, gap analysis, technical file index. A 4–12 week engagement reduced to a structured starting framework.

Accelerator

Three steps from concept to confident decision.

No regulatory expertise required to use PredicateIQ. No databases to query. No classification rules to memorise. Just describe your device.

Describe your device in plain English

Type a free-text description of your device concept — intended use, how it contacts the body, whether it's active or passive. No GMDN code, no regulatory background required. PredicateIQ maps it automatically to the right classification codes across all four databases.

Receive your Concept Intelligence Report in minutes

Four parallel research modules run simultaneously. Within 2–5 minutes you have a full structured report: predicate landscape across PARD, EUDAMED, and FDA; UK MDR classification with EU divergence flags; applicable standards with cost estimates; and clinical evidence density — all in one PDF.

Make informed decisions — or hand a consultant a head start

Founders use the report to pressure-test their concept, build investor decks, and brief RA consultants with confidence. Consultants use PredicateIQ as Draft 0 — arriving at client kickoff with the landscape already mapped, the flags already surfaced, and the predicate file already started.

What winning looks like.

PredicateIQ serves two heroes. The outcomes are different — the underlying capability is the same.

For RA consultancies

You deliver more.
For more clients.
Under your own brand.

PredicateIQ runs the research. You apply the judgment. The white-label output means every predicate file, CER draft, and landscape report goes out under your firm's name — indistinguishable from a manually produced deliverable.

Handle 5× the concept volume with the same team

White-label PDF export with your firm's logo and colours

Arrive at kickoff with Draft 0 already done

Full Module 7 CER workflow engine on Accelerator tier

For MedTech founders

Know before
you build.
Before you spend.

The regulatory questions that cost £8k–£20k and 4 weeks to answer at concept stage now take 5 minutes. Use that clarity to build better, pitch stronger, and avoid the regulatory surprises that sink devices at submission.

Know your UK device class before spending on development

Identify predicate devices and equivalence gaps early

Build investor decks with real regulatory foundations

Brief RA consultants from a position of knowledge

Without PredicateIQ, the failure modes are expensive. Wrong predicate selection forces a clinical trial instead of a 510(k). Missing the NI bifurcation means two separate submission tracks you didn't budget for. A weak equivalence argument gets rejected at Notified Body stage. These are the outcomes PredicateIQ is designed to catch at week one — not month six.

Three live regulatory changes are creating
immediate urgency in the UK MedTech market.

These aren't future risks. They're active compliance challenges for UK MedTech companies right now, in Q2 2026.

Live 1 April 2026

MHRA Annual Fee Transition — every DORS account is reviewing its GMDN footprint

The MHRA replaced the one-off £261 registration fee with £300 per GMDN Level 2 category, annually. Every manufacturer with UK-registered devices is right now auditing their GMDN codes. Non-payment leads to PARD removal and market access suspension. PredicateIQ's GMDN Portfolio Audit is built for this moment.

Live 23 February 2026

PARD brand and trade name fields — new data that didn't exist 10 weeks ago

For the first time, PARD includes brand and trade names. Before this date, searching for registered UK devices by what they do was practically impossible. PredicateIQ has indexed these fields with semantic search — surfacing competitors a founder never knew were registered in the UK.

Effective 28 May 2026

EUDAMED / Northern Ireland bifurcation — a dual-registration world from May

From 28 May, most devices must be registered in EUDAMED for EU and Northern Ireland. MHRA registration no longer applies to NI devices. Any manufacturer selling into both GB and NI now faces two separate regulatory tracks. PredicateIQ's Module 2 flags this divergence explicitly on every report.

One platform. Three tiers.

Built for Founders at concept stage and RA consultancies at scale. White-label output turns PredicateIQ from a tool you use into a tool you deliver under your own name.

Founder

£299 /mo

3 reports / month

For solo founders and pre-seed startups running initial concept validation.

3 concept intelligence reports per month

Full regulatory pathway analysis

PARD + EUDAMED + FDA search

Standards mapping with cost estimates

Clinical evidence density map

Predicate chain tracing + MAUDE enrichment

Start with Founder

Bring a real concept.
We'll run it live.

No slides. No pitch. Just your actual device concept — or a current client brief — run through PredicateIQ in real time so you can see exactly what the report produces.

First name

Last name

Work email

Organisation

I am a...

Device concept (optional)

No commitment. We'll respond within 24 hours.

Four questions stand between your device ideaand any serious development decision.

PredicateIQ is the Senior RA consultant's power tool — and the Founder's early warning system.

Three steps from concept to confident decision.

What winning looks like.

Three live regulatory changes are creatingimmediate urgency in the UK MedTech market.

One platform. Three tiers.

Bring a real concept.We'll run it live.

Four questions stand between your device idea
and any serious development decision.

Three live regulatory changes are creating
immediate urgency in the UK MedTech market.

Bring a real concept.
We'll run it live.