Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

bisphenol A; 4,4'-isopropylidenediphenol

EC / List no: 201-245-8 CAS no: 80-05-7
EU CLP (1272/2008)
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
R Toxic for reproduction (article 57c)

END Endocrine disrupting properties (Article 57(f) - human health)

ENDE Endocrine disrupting properties (Article 57(f) - environment)