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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 03 May 2024. Database contains 4753 unique substances/entries.
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203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
207-964-3
503-30-0
Flam. Liq. 2; Acute Tox. 4
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
209-663-2
589-90-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
204-661-8
123-91-1
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
218-817-8
2243-62-1
Carc. 2
236-948-9
13560-89-9
yes
239-139-9
15087-24-8
yes
204-081-5
115-31-1
Acute Tox. 4
246-011-6
24083-03-2
Acute Tox. 4
201-162-7
78-96-6
Skin Corr. 1B
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
209-990-0
600-25-9
Acute Tox. 4
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
203-696-6
109-69-3
Flam. Liq. 2
208-846-4
543-59-9
Flam. Liq. 2; Acute Tox. 4
208-749-7
540-54-5
Flam. Liq. 2; Acute Tox. 4
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
216-374-5
1569-02-4
Flam. Liq. 3; STOT SE 3
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
219-989-7
2592-95-2
Expl. 1.3
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
210-946-8
626-38-0
Flam. Liq. 3
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
202-155-1
92-43-3
Acute Tox. 4
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
214-012-0
1072-63-5
Repr. 1B
yes
282-263-3
84145-37-9
Flam. Liq. 3
203-872-2
111-46-6
Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1

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