1Describe a practical approach to implementing MDR/IVDR compliance at hospital or facility level
2Identify the key stakeholders and governance structures needed for a hospital MDR/IVDR programme
3Explain how to integrate device traceability and incident reporting into existing HSE workflows
4Develop an awareness of procurement, training, and audit requirements under the new regulations
Content reviewed: March 2026
Educational content only — this training does not replace your facility's official policies or HPRA guidance. Not an accredited or verified course.
Knowledge Check
8 questions · 80% required to pass
Q1.A theatre nurse reports inconsistent power output from an electrosurgical unit. Two surgeons have independently noticed the issue. Clinical engineering has not yet been contacted. What is the correct first response?
Q2.Your hospital's IMDMC discovers that the same infusion pump model is causing alarm failures across 3 wards. The neighbouring hospital in the same region reports identical problems. Which committee should coordinate the cross-site response?
Q3.During a risk-based audit, you're asked to verify the compliance status of a Class IIb patient monitor used in the ED. Which of the following would the auditor check?
Q4.The annual QA+I Self-Assessment reveals your hospital scores poorly on the "Capability" theme — only 55% of staff using high-risk devices have completed required training. What should happen?
Q5.A clinical engineering manager discovers during planned preventive maintenance (PPM) that a patient monitor intermittently drops SpO₂ readings. It passes self-test but fails under load. What is the appropriate risk classification for this finding?
Q6.A procurement officer wants to purchase a surgical instrument set from a new supplier. The supplier provides CE marking on the packaging but cannot supply a Declaration of Conformity when requested. What should happen?
Q7.Your hospital receives a Field Safety Notice (FSN) from a device manufacturer about a software update needed for ventilators currently in use across your ICU and HDU. What is the correct institutional response?
Q8.Which of the following best describes the accountability of ALL healthcare staff (including you) under HSE medical device governance policy?