EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 May 2024. Database contains 4753 unique substances/entries.
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419-620-1
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Skin Sens. 1
UK-103,449-BV
427-100-0
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
OA 8523
402-460-1
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Skin Irrit. 2; Skin Sens. 1
TFA-4713
418-960-8
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Skin Corr. 1B; Skin Sens. 1
444-320-2
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Acute Tox. 4
430-790-6
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-730-9
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Eye Dam. 1
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yes
430-580-4
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Skin Irrit. 2
424-660-8
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STOT RE 2; Eye Dam. 1; Skin Sens. 1

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