Plain-English articles on MDR, IVDR, and medical device regulation for healthcare professionals. Written for ward-level staff, not regulatory consultants.
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.
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.
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.
Why clinical and biomedical engineers are central to MDR/IVDR compliance in hospitals. Device lifecycle management, procurement, risk assessment, and PRRC responsibilities.
More articles coming soon. Want to suggest a topic? Get in touch.