MIVDR ReaderEU medical device regulations
Home

Readability & Display

Reviewed guidance topic

Hazardous substances (CMR and endocrine disruptors)

Hazardous substances in medical devices, including carcinogenic, mutagenic, or toxic-to-reproduction substances and endocrine disruptors.

Official catalogue · non-binding

Hazardous substances (CMR and endocrine disruptors) guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

Browse topics
SCHEER guidelinesUpdate on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devicescovering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) propertiesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other guidance documents
Published
June 2024
Topics

Source document

  • SCHEER guidelinesPDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.