Why this training exists, who built it, and what it covers.
EU Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 fundamentally changed how medical devices are governed across European hospitals. Yet most frontline healthcare staff — nurses, doctors, technicians, procurement officers — receive little or no structured training on what these regulations mean for their daily work.
This platform exists to close that gap. We provide free, accessible, self-paced training specifically contextualised for Irish and EU healthcare settings, with references to HPRA guidance, HSE structures, and real-world clinical scenarios.
This platform was developed by a clinical engineering professional working within the Irish healthcare system, with direct experience in medical device management, MDR/IVDR compliance, risk management, and hospital technology governance.
The content draws on practical, hands-on knowledge of how EU regulations intersect with day-to-day hospital operations — from incident reporting and device classification through to post-market surveillance and the emerging EU AI Act.
Transparency note: This is an independent educational initiative. It is not affiliated with, endorsed by, or funded by the HSE, HPRA, or any EU institution. Content is based on publicly available EU regulations and MDCG guidance documents.
Irish-contextualised: References to HPRA, HSE, and Irish healthcare structures throughout — not generic EU content.
Practical, not theoretical: Ward-level scenarios, incident reporting exercises, and device classification walkthroughs using real-world examples.
Free and open: Core training modules are available at no cost. We believe regulatory literacy is a patient safety issue, not a paywalled commodity.
Continuously updated: Content is reviewed against the latest MDCG guidance documents, HPRA notices, and regulatory developments.
This platform is not accredited by any statutory or professional body. Certificates issued confirm completion of our educational modules only and should not be presented as formal CPD accreditation. Always defer to your facility’s policies, your clinical engineering department, and the HPRA for site-specific guidance.