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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 19 kwietnia 2024. Database contains 4753 unique substances/entries.
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135821-03-3
yes
-
135821-74-8
yes
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
221-695-9
3194-55-6
Repr. 2; Lact.
yes
271-094-0
68515-51-5
yes
271-093-5
68515-50-4
Repr. 1B
yes
284-032-2
84777-06-0
Repr. 1B
yes
272-013-1
68648-93-1
yes
276-158-1
71888-89-6
Repr. 1B
yes
271-084-6
68515-42-4
Repr. 1B
yes
203-977-3
112-49-2
Repr. 1B
yes
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
236-948-9
13560-89-9
yes
-
-
yes
239-139-9
15087-24-8
yes
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
214-012-0
1072-63-5
Repr. 1B
yes
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
236-236-8
13252-13-6
yes
218-173-8
2062-98-8
yes
223-383-8
3864-99-1
yes
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
247-384-8
25973-55-1
yes
253-037-1
36437-37-3
yes
243-816-4
20427-84-3
yes
230-770-5
7311-27-5
yes
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
223-346-6
3846-71-7
yes
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
211-765-7
693-98-1
Repr. 1B
yes
687-833-9
1119449-38-5
yes
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
604-395-6
14409-72-4
yes
247-816-5
26571-11-9
yes
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
209-218-2
561-41-1
yes

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