Artwork compliance is non-negotiable. The label and Instructions for Use (IFU) must meet precise regulatory requirements before a device can be placed on the market. Any gap or error can result in non-compliance, delayed approvals, or Notified Body rejections.
This template provides a checklist for reviewing and approving all artwork contents against Regulation (EU) 2017/745 Annex I Chapter III, ISO 15223-1, and ISO 20417, ensuring every mandatory element across the label and IFU is present and accurate.
By systematically working through each checklist item, manufacturers can identify and address gaps in their artwork before submission, reducing the risk of delays or rejections during the conformity assessment process.
It serves as the final verification step before artwork is approved for production, ensuring manufacturers can demonstrate full compliance with labelling requirements.
This template is built by experienced regulatory professionals, ensuring every artwork review is thorough and submission-ready.
Price: $100
