MDR/UKCA Gap Assessment & Roadmap
Early, practical advice - what’s missing, what matters, and the least-effort path to a compliant launch.
Who this is for (and when to do it)
- Founders/CTOs pre-scale who want clarity before spending on full QMS/V&V.
- Teams with a prototype or PoC asking “are we on the right regulatory track?”
- Startups switching EU ↔ UK paths post-Brexit and unsure what’s changed.
- Anyone who’s inherited partial docs and needs a straight yes/no on gaps.
Outcome: a short, honest plan that prevents rework and dead ends.
What you’ll get
- Gap map against MDR/UKCA essentials (classification, route, tech file basics, vigilance, labelling).
- Priority list – must-do vs can-wait, with rough effort/time.
- Right-sized roadmap (6-12 weeks) tied to your actual device and resources.
- Risk snapshot (ISO 14971) so design choices don’t fight compliance later.
- Q&A session with our team
What we look at
Device & claims
Intended use, indications, clinical context
Class assumptions and borderlines (EU/UK differences)
Design & evidence
State of design inputs/traceability
PoC/prototype evidence; what will count later
Quality & process
What you actually need from ISO 13485 now vs later
Supplier control basics; change control hygiene
Documentation & labelling
What exists, what’s missing, what can be “lite” for now
UDI/label, IFU direction, post-market basics
FAQs
No – this is an early advisory sprint. We right-size what to do now so the later QMS/V&V work is faster and cheaper.
We’ll provide a justified view and common regulator interpretations. Formal confirmation still sits with the notified/approved bodies.
Yes: gap map, priorities and a 6-12-week roadmap. We can record the workshop if you want.
Intended use/claims, any specs, current labels/IFU drafts, and a realistic launch target.
