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MedTech Europe publishes guidance on (Full) Material Declaration

Posted on 02.04.2019

MedTech Europe’s environmental groups have adopted a guidance document on the benefits of full material declaration. The guidance is intended to ensure common understanding in the field of 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.

The rationale for such guidance is to provide members with a common interpretation of the different requirements provided by the entry into force of new regulations such as REACH, the Medical Device Regulation (MDR), the California Proposition 65 List and the inclusion of IVDs and medical devices into the scope of the RoHS Directive. Due to these regulations as well as to increasing customer requirements on the chemical composition of products, the demand for information on material compositions of medical technology products has increased rapidly.

The guidance is available on our website and will be shared with external stakeholders, including supplier and customer organisations. MedTech Europe members are encouraged to use it as a reference document when communicating requests for material declaration up their supply chain.