Healthcare / Medical Devices

As with pharmaceutical/medicinal products, the safety and security of medical devices in the supply chain is critical.

Compliance with strict regulations, along with traceability, is necessary when moving products from manufacturer to patient, within compliance.
”The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. However, due to the global outbreak of Covid-19, full application of the MDR has been postponed and will become fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.” HPRA