--- title: "United Kingdom MHRA - Cybersecurity Submission Playbook" description: "How to submit a medical device to MHRA in United Kingdom: step-by-step route, evidence checklist, common rejections, and typical review timeline. Compared wit" lang: en json-ld: | [ { "@context": "https://schema.org", "@type": "WebSite", "name": "The Medical Device Cybersecurity Crosswalk", "alternateName": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "description": "Compare FDA, EU MDR, MHRA, PMDA, NMPA, TGA, MFDS and Health Canada medical device cybersecurity requirements across 29 jurisdictions." }, { "@context": "https://schema.org", "@type": "Organization", "name": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "logo": "https://mdccrosswalk.com/favicon.png", "sameAs": [ "https://bluegoatcyber.com" ], "description": "An editorial reference comparing global medical-device cybersecurity regulations. Maintained by Blue Goat Cyber." }, { "@context": "https://schema.org", "@type": "Article", "headline": "United Kingdom - UK MDR 2002 (as amended) + MHRA Cyber Guidance", "description": "How to submit a medical device to MHRA in United Kingdom: step-by-step route, evidence checklist, common rejections, and typical review timeline. Compared wit", "author": { "@type": "Organization", "name": "MDC Crosswalk" }, "publisher": { "@type": "Organization", "name": "MDC Crosswalk" }, "image": "https://mdccrosswalk.lovable.app/favicon.png", "datePublished": "2026 (Draft Medical Devices (Amendment) Regulations 2026 published; MHRA stakeholder impact survey underway alongside the Feb 2026 CE-recognition consultation)", "about": "Medicines and Healthcare products Regulatory Agency", "dateModified": "2026-07-16", "mainEntityOfPage": "https://mdccrosswalk.lovable.app/standards/uk" }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "Is SBOM required for medical devices in United Kingdom?", "acceptedAnswer": { "@type": "Answer", "text": "Recommended. Not mandated; encouraged via NCSC guidance and aligns with FDA expectations for dual-market devices." } }, { "@type": "Question", "name": "What does MHRA require for pre-market cybersecurity?", "acceptedAnswer": { "@type": "Answer", "text": "Risk-based, leverages BS EN 81001-5-1 and FDA-aligned evidence. UKCA marking with grace period for CE-marked devices." } }, { "@type": "Question", "name": "What are the post-market cybersecurity obligations under MHRA?", "acceptedAnswer": { "@type": "Answer", "text": "MORE vigilance reporting + DTAC for NHS deployment + DSPT for connected services." } }, { "@type": "Question", "name": "What is the penalty for non-compliance with MHRA cybersecurity rules?", "acceptedAnswer": { "@type": "Answer", "text": "Market removal, criminal liability under Consumer Protection Act." } }, { "@type": "Question", "name": "How much of my FDA cybersecurity package is reusable in United Kingdom?", "acceptedAnswer": { "@type": "Answer", "text": "Roughly 80% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report)." } }, { "@type": "Question", "name": "Why do MHRA submissions get rejected for \"ukrp details missing from labeling\"?", "acceptedAnswer": { "@type": "Answer", "text": "Add UKRP name and address to device labeling and IFU before AB audit." } }, { "@type": "Question", "name": "Why do MHRA submissions get rejected for \"reliance on ce certificate near 2030 sunset\"?", "acceptedAnswer": { "@type": "Answer", "text": "Start UKCA transition planning 18-24 months before June 2030 to avoid AB bottleneck." } } ] }, { "@context": "https://schema.org", "@type": "HowTo", "name": "How to submit a medical device to MHRA", "description": "The UK continues to recognise CE-marked devices through 30 June 2030 while the post-Brexit framework catches up. MHRA's cybersecurity expectations mirror MDCG 2019-16 for now, with additional guidance on connected/AI devices published under the Software and AI as a Medical Device programme.", "totalTime": "0-4 weeks (CE recognition) or 10-16 months (UKCA).", "step": [ { "@type": "HowToStep", "position": 1, "name": "Decide CE recognition vs UKCA", "text": "CE recognition is the low-friction path until 30 June 2030; UKCA is required afterwards and for Northern Ireland-only products." }, { "@type": "HowToStep", "position": 2, "name": "Engage an Approved Body (UKCA path)", "text": "AB capacity in the UK is limited; book 6-12 months ahead for Class IIa+ devices." }, { "@type": "HowToStep", "position": 3, "name": "Package cybersecurity evidence", "text": "MHRA accepts MDCG 2019-16-style documentation as-is; add UK-specific labeling for the UKRP." }, { "@type": "HowToStep", "position": 4, "name": "Register with MHRA", "text": "All devices placed on the GB market must be registered by the UKRP within grace-period deadlines." } ] }, { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://mdccrosswalk.lovable.app/" }, { "@type": "ListItem", "position": 2, "name": "Standards" }, { "@type": "ListItem", "position": 3, "name": "United Kingdom" } ] } ] --- [ The Crosswalk ](/) [Overview](/)[Playbook](/playbook)CompareReference [New Per-page social previews and this changelog ](/changelog "Per-page social previews and this changelog") Search⌘K 1. [Home ](/) 2. Standards 3. United Kingdom MHRA # ![Flag of United Kingdom](/flags/gb.svg)United Kingdom - MHRA Guidance Last updated · 2026 (Draft Medical Devices (Amendment) Regulations 2026 published; MHRA stakeholder impact survey underway alongside the Feb 2026 CE-recognition consultation) Verified · 2026-07-16 UK MDR 2002 (as amended) + MHRA Cyber Guidance Share Copy link X LinkedIn Email Sources verified · 2026-07-16 Cross-checked against MHRA roadmap and DTAC/DSPT references. Authority Medicines and Healthcare products Regulatory Agency Enforced Reform program 2024–26 Legal framework UK MDR 2002 + DTAC + NHS DSPT FDA package reuse ~80% [Editorial estimate · how →](/methodology#fda-reuse) ## Scope Devices marketed in Great Britain (Northern Ireland follows EU MDR via the Windsor Framework). Software as a Medical Device addressed by separate MHRA Change Programme. Pre-market Risk-based, leverages BS EN 81001-5-1 and FDA-aligned evidence. UKCA marking with grace period for CE-marked devices. Post-market MORE vigilance reporting + DTAC for NHS deployment + DSPT for connected services. SBOM Recommended Not mandated; encouraged via NCSC guidance and aligns with FDA expectations for dual-market devices. Vulnerability disclosure Encouraged via the NCSC Vulnerability Disclosure Toolkit. Penalty Market removal, criminal liability under Consumer Protection Act. ## Unique requirements - 01 DTAC clinical safety, data protection, technical assurance for NHS - 02 DSPT compliance for hosted services - 03 International recognition route for FDA/Health Canada/TGA approvals (Draft 2026 Regulations codify the pathway; MHRA impact survey open) ## Highlights - Pragmatic FDA/EU dual-recognition - DTAC required for NHS deployment - Future divergence from EU MDR ## Aligns with IMDRF N60 BS EN 81001-5-1 NCSC CAF ## Timeline 1. Jan 2021 Brexit transition ends, UKCA introduced 2. Sep 2021 MHRA SaMD Change Programme launched 3. 2024 International Recognition route consultation 4. Feb 16 2026 MHRA consultation on indefinite recognition of CE-marked devices launched (closed; analysis underway) 5. 2026 Draft Medical Devices (Amendment) Regulations 2026 published for consultation; MHRA impact survey open ## Key documents [ MHRA Software & AI as a Medical Device Change Programme https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme ](https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme)[ NHS Digital Technology Assessment Criteria (DTAC) https://transform.england.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/ ](https://transform.england.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/)[ NCSC Vulnerability Disclosure Toolkit https://www.ncsc.gov.uk/information/vulnerability-disclosure-toolkit ](https://www.ncsc.gov.uk/information/vulnerability-disclosure-toolkit) ## How to submit in United Kingdom Playbook reviewed · 2026-07-16 Submission route UKCA marking (or CE recognition through 30 June 2030) with an Approved Body, plus MHRA registration The UK continues to recognise CE-marked devices through 30 June 2030 while the post-Brexit framework catches up. MHRA's cybersecurity expectations mirror MDCG 2019-16 for now, with additional guidance on connected/AI devices published under the Software and AI as a Medical Device programme. [Authority portal](https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety) ### Step-by-step 1. Step 01 Decide CE recognition vs UKCA CE recognition is the low-friction path until 30 June 2030; UKCA is required afterwards and for Northern Ireland-only products. 2. Step 02 Engage an Approved Body (UKCA path) AB capacity in the UK is limited; book 6-12 months ahead for Class IIa+ devices. 3. Step 03 Package cybersecurity evidence MHRA accepts MDCG 2019-16-style documentation as-is; add UK-specific labeling for the UKRP. 4. Step 04 Register with MHRA All devices placed on the GB market must be registered by the UKRP within grace-period deadlines. ### Evidence checklist Item Level FDA equivalent Notes MDCG 2019-16-style cyber documentation Required SPDF UKRP appointment (non-UK manufacturers) Required — IEC 81001-5-1 evidence Recommended — PSTI-aligned vulnerability disclosure policy Recommended — Not legally required for medical devices but expected best practice. ### Common MHRA rejections UKRP details missing from labeling Common Fix · Add UKRP name and address to device labeling and IFU before AB audit. Reliance on CE certificate near 2030 sunset Occasional Fix · Start UKCA transition planning 18-24 months before June 2030 to avoid AB bottleneck. ### Typical timeline End-to-end window: 0-4 weeks (CE recognition) or 10-16 months (UKCA). Phase 01 CE recognition path 0-4 weeks MHRA registration only, if you already hold a valid CE certificate. Phase 02 UKCA path (Class IIa+) 10-16 months Includes AB queue + review. [Previous ![Flag of European Union](/flags/eu.svg)European Union ](/standards/eu)[Next ![Flag of Japan](/flags/jp.svg)Japan ](/standards/jp) ## MHRA head-to-head [ Compare ![Flag of United Kingdom](/flags/gb.svg)MHRAvs ![Flag of United States](/flags/us.svg)FDA 524B Open comparison ](/compare/fda-vs-mhra)[ Compare ![Flag of United Kingdom](/flags/gb.svg)MHRAvs ![Flag of European Union](/flags/eu.svg)EU MDR Open comparison ](/compare/eu-mdr-vs-uk-mhra) ## Related markets [![Flag of Taiwan](/flags/tw.svg) Taiwan ~80% FDA reuse ](/standards/tw)[![Flag of South Africa](/flags/za.svg) South Africa ~80% FDA reuse ](/standards/za)[![Flag of Malaysia](/flags/my.svg) Malaysia ~80% FDA reuse ](/standards/my)[![Flag of Philippines](/flags/ph.svg) Philippines ~80% FDA reuse ](/standards/ph) ## Frequently asked about United Kingdom ### Is SBOM required for medical devices in United Kingdom? Recommended. Not mandated; encouraged via NCSC guidance and aligns with FDA expectations for dual-market devices. ### What does MHRA require for pre-market cybersecurity? Risk-based, leverages BS EN 81001-5-1 and FDA-aligned evidence. UKCA marking with grace period for CE-marked devices. ### What are the post-market cybersecurity obligations under MHRA? MORE vigilance reporting + DTAC for NHS deployment + DSPT for connected services. ### What is the penalty for non-compliance with MHRA cybersecurity rules? Market removal, criminal liability under Consumer Protection Act. ### How much of my FDA cybersecurity package is reusable in United Kingdom? Roughly 80% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report). Sponsored note · Blue Goat Cyber Submitting to MHRA? Get a second pair of eyes before you file. Blue Goat Cyber has packaged cybersecurity evidence for United Kingdom alongside 37 other markets. We'll tell you what to keep, what to rework, and what's missing, in 30 minutes. [Talk through your MHRA submission](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) The Crosswalk An independent reference for global medical device cybersecurity standards. A field guide for MedTech innovators and RA/QA teams charting an international path. Resource - [Comparison matrix](/compare) - [Global playbook](/playbook) - [Glossary](/glossary) - [FAQ](/faq) Sponsored by [Blue Goat Cyber ↗](https://bluegoatcyber.com) Editorially independent. Sponsorship keeps it free. © 2026 The Crosswalk. Not legal advice. Validate every requirement against current regulator publications.