🩺 How to approach medical device regulation for HealthTech

Summary

• This guide outlines the complex but essential regulatory requirements for HealthTech companies developing Software or AI as a Medical Device (SaMD/AIMD).
• It explains the end-to-end regulatory lifecycle—from defining intended use to post-market surveillance—based on key frameworks like the UK MDR, EU MDR, and ISO 13485.
• With insights from industry leaders like Hardian Health, the resource equips innovators with the knowledge to secure UKCA/CE marking and build safe, evidence-based products.

What this carousel covers

• Regulatory definitions and classification of SaMD, including risk stratification (Class I to III)
• Critical components like the Intended Use Statement, QMS, Medical Device File, Clinical Evaluation Report (CER), and Post-Market Surveillance (PMS)
• The role of independent Notified/Approved Bodies, ISO 13485 alignment, and the importance of Verification & Validation (V&V)
• How to register your product (e.g. EUDAMED, MHRA), assign a Person Responsible for Regulatory Compliance (PRRC), and implement ongoing PMCF

Key takeaways

• SaMD must follow medical device regulations just like physical devices—this includes clinical evidence, risk assessments, and quality processes
• Building a QMS is legally required and must be ingrained in your operations from day one
• CERs and clinical evaluation plans aren’t one-time tasks—they need to be maintained through real-world data and PMCF
• Regulatory readiness is not just about compliance—it’s about building safer, credible, and scalable digital health solutions