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 14 lipnja 2024. Database contains 4917 unique substances/entries.
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P Parasites
Details
269-511-6
68259-08-5
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
228-098-2
6130-43-4
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)
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700-242-3
62037-80-3
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)
Details
604-314-4
142844-00-6
C Carcinogenic (article 57a)
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603-801-9
134237-50-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
263-004-3
61788-76-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
272-924-4
68920-70-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
285-195-2
85049-26-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-931-7
84776-07-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-376-5
1372804-76-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-504-6
85536-22-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-930-1
84776-06-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
281-985-6
84082-38-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
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B Bacteria and similar species
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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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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)
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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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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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