ISO 13485 Label Review and Approval Procedure

Review and approve medical device labels, packaging and instructions for use (IFU) with this editable ISO 13485 Label Review and Approval Procedure. The included forms support unit, box and shipper label checks, IFU content review, approvals and controlled labeling revisions.

The Label Review and Approval Procedure applies to all finished devices and their respective labeling. The Label Review and Approval Procedure includes detailed label content review for unit, box, shipper labels and approval forms. The Label Review and Approval Procedure also includes detailed IFU content and review form that is made part of the review and approval cycle.

The labeling process follows artwork or text from creation to cross-functional review and approval. Reviewers check the current device information and applicable labeling requirements before Document Control releases an approved version. Operations is notified when the new labeling is available and implements the change using controlled files. This links the label used in production to the approved specification and its revision history.

The Document Control Procedure addresses release and revision control for approved documents used with this labeling process.

For identification assignment and related database records, see the Unique Device Identification Procedure.

For expiration-date evidence behind an approved label, see the Product Stability and Shelf-Life Procedure. For EU conformity and CE marking activities, see the CE Marking Procedure. Both are included with this label review procedure in the Medical Device Labeling Procedure Bundle.

Supplied as an editable Microsoft Word document as a digital download.

Part of a procedure bundle

This document is also included in Medical Device Labeling Procedure Bundle. Explore the bundle for the related documents.