Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

4. Packaging

• Addition of UDI to labels • Readable format • Availability on all labels (e.g. small reagents) • Eudamed • Additional symbol in draft relevant of IVDs • Beware of the translation costs

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5. Quality Management System requirements

• Person Responsible for Regulatory Compliance • Post-Market Surveillance and Post-Market Follow Up Plan • Economic Operators

Building a QMS under the IVDR is just about jumping a hurdle,.. its jumping a hurdle onto a ledge. Greater time, resource and effort will be required in a post IVDR world

This Photo by Unknown Author is licensed under CC BY

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