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 19 srpnja 2024. Database contains 4917 unique substances/entries.
Filter the list

 
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
-
P Parasites
Details
-
-
P Parasites
Details
626-360-4
15244-35-6
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
263-467-1
62229-08-7
R Toxic for reproduction (article 57c)
Details
616-572-5
7790-84-3
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
-
-
P Parasites
Details
-
-
P Parasites
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
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.
Details
-
-
F Fungi
Details
231-556-4
7632-04-4
R Toxic for reproduction (article 57c)
Details
243-518-4
20109-59-5
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)
Details
239-172-9
15120-21-5
R Toxic for reproduction (article 57c)
Details
616-541-6
7789-12-0
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
-
-
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.
Details
-
-
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.
Details
-
-
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.
Details
234-363-3
11120-22-2
R Toxic for reproduction (article 57c)
Details
272-271-5
68784-75-8
R Toxic for reproduction (article 57c)
Details

Export search results to: