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).

2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid

EC / List no: 236-236-8 CAS no: 13252-13-6
EU REACH: List of SVHC
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)

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