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).

Last updated 04 listopada 2024. Database contains 4917 unique substances/entries.
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B Bacteria and similar species
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P Parasites
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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P2-800; P2-935LV
415-870-0
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Skin Sens. 1
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EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1
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RED MDO 358
414-620-8
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Eye Dam. 1; Skin Sens. 1
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DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
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Skin Sens. 1
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VERNETZER TMAG
412-790-8
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Carc. 1B; Muta. 2; STOT RE 2
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REACTIVE YELLOW FC 75560
419-450-8
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Skin Sens. 1
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OLOA 224 (OIL FREE)
420-470-4
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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