For Healthcare Professionals in Ireland & the EU
Self-paced training on EU Medical Devices Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) — covering classification, incident reporting, vigilance, and your responsibilities under the new regulatory framework.
Includes HPRA reporting guidance and references specific to HSE hospital settings.
Educational Content Only
This training is for informational purposes and does not constitute professional, legal, or regulatory advice. It is not an accredited, certified, or externally verified course. It does not replace your facility's official policies, procedures, or guidance issued by the HPRA or other competent authorities. Always consult your institution's clinical engineering department and official regulatory sources for site-specific requirements.
Practical, regulation-referenced content designed for clinical and biomedical engineering staff who use or manage medical devices in their daily work.
Step-by-step guidance through MDR (EU) 2017/745 and IVDR (EU) 2017/746, with practical examples relevant to Irish healthcare settings.
Ask questions about MDR/IVDR obligations, HPRA reporting requirements, or device classification and get referenced answers.
Searchable dictionary of MDR/IVDR terminology with Article references — from "Authorised Representative" to "UDI-DI".
Walk through the MDR Annex VIII classification rules with real device examples to determine the correct risk class.
Work through realistic ward-level scenarios — incident reporting, device recalls, and FSCA responses.
Content includes HPRA reporting pathways, Irish incident reporting portals, and references relevant to HSE facilities.
Access modules on tablets and phones — designed for use during breaks or between shifts.
Download verifiable PDF certificates on completion, suitable for your CPD portfolio and annual appraisal records.
Use these alongside the training modules or as standalone quick-reference resources.
Ask MDR/IVDR questions in plain language
Trained on MDR, IVDR, and MDCG guidance documents. Ask about classification rules, reporting timelines, HPRA obligations, or any regulatory term.
Six modules covering the regulatory knowledge that clinical and technical staff need for day-to-day device management and compliance.
Core regulatory framework, key changes from the Directives, and what they mean for clinical staff
MDR Annex VIII rules, IVDR risk classes, and practical classification exercises
Your obligations under MDR Article 14, incident reporting to the HPRA, and device traceability
PMS, vigilance reporting timelines, FSCAs, and HPRA notification requirements
Scenario-based exercises: incident triage, recall management, and clinical decision-making
Knowledge check covering all modules — pass to earn your CPD certificate
Each module can be completed in short sessions and progress is saved automatically, so you can pick up where you left off between shifts.
Works on desktop, tablet, and phone. Use it at your workstation, in the staff room, or on the ward.
Modules range from 15 to 40 minutes. Complete a section during a break or quiet period — no need for a full study block.
On completion, download a PDF certificate with your name, date, score, and a unique certificate ID — suitable for your CPD portfolio.