EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

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).

RELEVANT LEGISLATION
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Perfluoroheptanoic acid; tridecafluoroheptanoic acid

EC / List no: 206-798-9 CAS no: 375-85-9
EU CLP (1272/2008)
Repr. 1B; STOT RE 1
EU REACH: List of SVHC
R Toxic for reproduction (article 57c)

PBT Persistent, Bioaccumulative and Toxic (article 57d)

VPVB very Persistent and very Bioaccumulative (article 57e)

HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)

E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)