EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Last updated 29 March 2024. Database contains 4753 unique substances/entries.
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DAM 520
413-440-7
112006-75-4
Skin Sens. 1
223-346-6
3846-71-7
yes
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
429-430-0
444-14-4
Acute Tox. 4
426-540-0
2973-59-3
Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
204-502-2
121-87-9
Acute Tox. 4
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
201-956-3
89-98-5
Skin Corr. 1B
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
202-433-2
95-57-8
Acute Tox. 4
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
202-424-3
95-49-8
Acute Tox. 4
423-740-1
10461-98-0
Acute Tox. 4
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
431-400-7
57374-49-9
Skin Sens. 1
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-542-8
108-01-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2

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