Guidance on Material Declaration in the in vitro diagnostic medical device and medical device industry

This guidance provides a valuable resource on material declaration for MedTech Europe members as well as external stakeholders, notably suppliers and customers of the medical technology industry. It is intended to ensure common understanding on material declaration, which is used to transfer information on the chemical composition of products, and related regulatory information, within the supply chain to allow the corresponding downstream user to comply with constantly evolving global regulatory requirements and appropriately deal with shifting stakeholder expectations.