Rebecca Wilson
Founder & Senior Clinical Governance Specialist
Medical device compliance
UK medical device compliance, UKCA, MHRA & SaMD
Classification, technical file, QMS, UKCA marking, MHRA registration and post-market surveillance for software (SaMD) and hardware devices placed on the GB market.
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 a Clinical Safety Officer
Book a free call with a DigiSafe CSO. We'll scope the work, timelines and cost, 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.
Zara Mahmood
Occupational Therapist & CSO
Dr Stephen Eberwein
GP & CSO
Steve Robson
Nurse & Senior CSO
Matthew Olsson
Business Development Manager & Senior CSO
Mona Kapinga
Pharmacist & CSO
Dr. Lizzie Marston
GP & Senior CSO
Suzanne Ash
Medical Device Expert, DPO
Stacey Dudley
Marketing Lead & Innovator Social Media Expert
Sharon Fisher
Executive Assistant
Every engagement starts with a 15-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.