Companies are faced with ever-increasing requirements to document and report chemical composition, to track the volumes of substances, and to document the origin of product components, etc. To assist in this, MedTech Europe (MTE) has published a new paper, ‘Guidance on Material Declaration in the In Vitro Diagnostic Medical Device and Medical Device Industry’. The document provides a high-level background on what a material declaration is, including:
Materials declarations have become necessary with the introduction of REACH, the Medical Device Regulation, the California Proposition 65 List and the inclusion of IVDs and medical devices into the scope of the RoHS Directive. The increased demand for information on material compositions for the purpose of compliance means that the regulatory requirements and the related requests can no longer be handled in the previous ad-hoc manner. Compliance with material‐related legal obligations is now essential for obtaining access to the particular markets.
The MTE paper provides definitions of key concepts, outlines industry best practices for materials declarations and gives details on how to deal with concerns over intellectual property. Companies are advised to take immediate steps in order to be able to manage current and future global substance restriction regulations.