Verifying compliance of medical devices and IVDs before using them for patient care

A new HPRA guide helps healthcare professionals, pharmacists, hospitals, laboratories, and other organisations check that CE-marked medical devices and in vitro diagnostic devices (IVDs) are compliant before using them in patient care. Carrying out verification checks helps reduce the risk of using non-compliant devices and supports patient safety. 

The guide provides practical information on how to carry out key compliance verification checks, including in the areas of:

• CE marking
• Declarations of conformity 
• Device traceability requirements 

This guidance has been developed to help healthcare organisations to meet their regulatory responsibilities and to support processes for procuring, managing and using CE-marked medical devices and IVDs. 

To support compliance activities, additional practical resources are available on our website section: Using medical devices and IVDs - guidance for health institutions and healthcare professionals. These include resources for managing corrective actions and information on the available routes for using medical devices and IVDs in Ireland.