Medical Device Labeling Procedure Bundle
Coordinate four connected medical device activities with editable procedures for label and IFU review, unique device identification (UDI), evidence supporting shelf-life claims, and EU CE marking. The CE Marking Procedure addresses broader conformity assessment and technical documentation, in addition to labeling. Adapt each procedure to your device and markets.
Supplied as editable Microsoft Word documents in a digital download.
Medical Device Labeling Procedure Bundle - Content
The Medical Device Labeling Procedure Bundle product includes the following procedures:
Label Review and Approval Procedure — The ISO 13485:2016 Label Review and Approval Procedure defines the process for creating, reviewing, revising and controlling device labeling for use on commercial product for human use.
Unique Device Identification Procedure — The Unique Device Identification (UDI) Procedure defines the process of creating, submitting and maintaining Unique Device Identification (UDI) codes.
Product Stability Shelf Life Procedure — The Shelf Life Procedure defines the required testing to support medical device shelf life claims.
CE Marking Procedure — Provides a method for maintaining CE technical documentation and device classification under Regulation (EU) 2017/745 (MDR).
Label and IFU review and controlled revisions
UDI assignment and registration records
Shelf-life evidence and expiration labeling
CE marking, conformity assessment and technical documentation
Browse the individual documents in this bundle
Practical guide
Read Medical Device Labeling, UDI and CE Marking: Keep Claims Aligned for workflow guidance, a checklist and common mistakes.
