Rebecca Wilson
Founder & Managing Director
What UK medical device compliance covers
UK medical device rules apply to any product intended for a medical purpose, including software (SaMD), AI, decision support and connected hardware. Manufacturers must classify the device, build a compliant technical file, operate a quality management system, and register with the MHRA.
For NHS-facing products, medical device compliance sits alongside DCB0129 and DTAC v2, DigiSafe covers all three so you don't get stuck between them.
Our medical device package
- Regulatory classification and pathway strategy
- Technical file / design dossier authoring
- ISO 13485 QMS setup and gap analysis
- IEC 62304 software lifecycle for SaMD
- UKCA marking and MHRA registration coordination
- UK Responsible Person via trusted partners
- Post-market surveillance, vigilance and PMCF planning
Frequently asked questions
Is my software a medical device?
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If your product diagnoses, prevents, monitors, predicts, treats or alleviates a disease, injury or disability, or supports a clinical decision that does, it is likely Software as a Medical Device (SaMD) and needs to be classified, registered with the MHRA and UKCA-marked.
What is UKCA marking?
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UKCA is the UK conformity mark for medical devices placed on the Great Britain market. It replaces CE marking for GB and requires demonstrating compliance with UK MDR 2002 (as amended).
Do I need MHRA registration?
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Yes. Manufacturers of medical devices placed on the GB market must register with the MHRA. A UK Responsible Person is required if the manufacturer is based outside the UK.
How does medical device compliance relate to DCB0129?
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They are separate regimes but overlap. DCB0129 covers clinical safety of Health IT in NHS use; UK MDR / UKCA covers safety and performance of the device itself. Most NHS-facing SaMD needs both.
Can DigiSafe act as our UK Responsible Person?
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We work with trusted UKRP partners and coordinate the whole pathway, classification, technical file, QMS, UKRP, MHRA registration and post-market surveillance, so you have one team end-to-end.
Related services
Talk to an Expert
Book a free call with a DigiSafe expert. We'll scope the work, timelines and the right partnership, plain English, no jargon.
Direct clinical access
Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.
Stacey Dudley
Chief Operating Officer
Alice Wood
Head of Clinical Safety and Compliance
Suzanne Ash
Medical Device and Compliance Expert
Tom Falcon
Medical Device and Compliance Expert
Steve Robson
Clinical Safety Officer, Nurse
Dr Lizzie Marston
Clinical Safety Officer, GP
Mona Kapinga
Clinical Safety Officer, Pharmacist
Dr Aleem Qureshi
Clinical Safety Officer, GP
Matthew Olsson
Clinical Safety Officer, Lead Trainer, Paramedic
Zara Mahmood
Clinical Safety Officer, Occupational Therapist
Shell Mcvey
Business Support Manager
Clarity
Marketing Partner & Digital Strategist
Clarity is our marketing partner, supporting DigiSafe and our clients with digital strategy, brand growth and social media.
Visit Clarity Media Co.Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.