Auditing and creating checklist for medical device labeling

The best guidance on which elements for medical devices must be on the labels is in section 23.1, 23.2, and 23.3 of the General safety and performance requirements (Annex 1 of the Medical device regulation 2017/745). So, create the checklist according to that and then audit the responsible person for preparing the labels according to all applicable requirements from section 23 of the General safety and performance requirements.

For more information, see:

• EU MDR Annex 1 - General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/