Reconciling Risks and Benefits: Manufacturer's Obligations for Hazardous Substances in Medical Devices and ComplyMarketHow streamlines compliance
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EU2017/745 Medical Device Regulation ("MDR") is carcinogenic, mutagenic, or reproductive toxicity in medical devices (CMR) and / or requires the regulation of endocrine disruptors. In this article, we will discuss how to use CMR and/or or endocrine disruptors, plus 0.1% threshold is exceeded.
Applies to:
Applicable products: Devices such as: , or any of its parts, or materials used in the equipment:
- invasive and in direct contact with the human body,
- Medicines, bodily fluids, or other substances containing gases (re)administered to/from the body, or
- Transporting or storing medicines, bodily fluids or substances (including gases) that are (re)administered to the human body.
Restrictions:
- Medical Device is a CMR and /or 0.1% endocrine disruptors weight/ weight(w/w) / component.
- medical devices are CLP restriction (EC）No 1272/2008Annex to VI3<span style="font-family: 'MS Gothic'; mso-bidi-font-family: 'MS Gothic';"> Category1A or 1B carcinogenic, mutagenic, or reproductive toxicity ('CMR' ) substance, or REACH restriction (EC）No 1907/2006 59Article and Biopesticide Products Regulation (EU)No 528/2012 5(3)It must not contain substances defined as endocrine disruptors in accordance with the article.
> Manufacturer's Obligations:
0.1% w/wIf the threshold of is exceeded, the manufacturer must:
- profit risk assessment and justify the technical file.
- device itself and / or on the packaging of each unit, or on the sales packaging if appropriate.
- include instructions for use in groups of patients who are particularly vulnerable to these substances.
- Maintain an online database > UDI
ComplyMarket can help:
- ComplyDoC: Intelligent IT for supply chain sustainability, chemical and product compliance management and the first open source code cloud solution.
- Ad Hoc Consulting: ComplyMarketWe are an experienced team that provides legal support for the MDR".