HPRA revises its guide for medical device distributors

The Irish Competent Authority for medical devices, the Health Products Regulatory Agency (HPRA) has updated its guidance for medical device distributors, making it relevant to compliance with the Medical Devices Regulation (MDR, 2017/745) rather than the Medical Device Directive (MDD, 93/42/EEC).

The guidance is published in ‘redline version’, so the changes from the previous version are obvious.

Copies can be obtained from here.