Plain-English articles on MDR, IVDR, and medical device regulation for healthcare professionals. Written for ward-level staff, not regulatory consultants.
12 pain points across 5 hospital departments — from ward-level recall failures to governance gaps. Each maps to training modules and practical content. The compliance problems nobody talks about.
A company sells a pump to your hospital. Five years later a safety alert arrives — sent to the email of whoever signed the original purchase order. How does it reach the ward? MDR Article 14 is helping Irish hospitals strengthen this chain.
Many hospital staff don’t recognise reportable incidents. The MDR Article 87 threshold, what to report to the HPRA, and the common near-misses that go unreported.
Resource pressure leads to quiet reuse of single-use devices in Irish hospitals. Ireland has not opted into the Article 17(2) exemption — reprocessing is prohibited. The law, the risks, and the alternatives.
Why clinical and biomedical engineers are central to MDR/IVDR compliance in hospitals. Device lifecycle management, procurement, risk assessment, and PRRC responsibilities.
Side-by-side comparison of the Medical Devices Regulation and the In Vitro Diagnostic Regulation. Classification rules, transition timelines, and what applies to your department.
Step-by-step guide for HSE hospital staff on reporting device incidents to the HPRA. Covers timelines, forms, what counts as a serious incident, and common mistakes.
The EU Medical Devices Regulation explained without the jargon. What it means for hospitals, what changed from the old Directives, and why it matters for patient safety.
More articles coming soon. Want to suggest a topic? Get in touch.