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).

benzo[a]pyrene; benzo[def]chrysene

EC / List no: 200-028-5 CAS no: 50-32-8
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
C Carcinogenic (article 57a)

M Mutagen (article 57b)

R Toxic for reproduction (article 57c)

PBT Persistent, Bioaccumulative and Toxic (article 57d)

VPVB very Persistent and very Bioaccumulative (article 57e)