Balancing risk and benefit: Manufacturer's obligations for hazardous substances in medical devices and how ComplyMarket can simplify compliance
The Medical Device Regulation (EU) 2017/745 ("MDR") requires the regulation of substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) and/or endocrine disrupting substances in medical devices. This article provides an overview of the regulations for CMR and/or endocrine disruptors in medical devices and the manufacturer's obligations if the 0.1% threshold is exceeded.
Subject Products:
Devices, or parts thereof or materials used therein, that:
- are invasive and come into direct contact with the human body,
- (re)administer drugs, body fluids, or other substances, including gases, from/to the body, o
- carry or store such drugs, body fluids or substances, including gases, to be (re)administered to the body.
Normative:
- Medical devices shall not contain CMR and/or endocrine disrupting substances in a concentration greater than 0.1% by weight/weight (w/w)/components.
- Medical devices must not contain substances that are carcinogenic, mutagenic or toxic for reproduction ('CMR'), category 1A or 1B, in accordance with Part 3 of Annex VI of the CLP Regulation (EC) No. 1272/2008, or substances defined as endocrine disruptors according to Article 59 of the REACH Regulation (EC) No. 1907/2006 and Article 5(3) of the Biocidal Products Regulation (EU) No. 528/2012.
Manufacturer's obligations:
If the 0.1% w/w threshold is exceeded, the manufacturer must:
- Carry out a risk-benefit assessment and justify it in the technical file.
- Label the presence of such substances on the device itself and/or on the packaging for each unit or, if appropriate, on the sales packaging, with the list of such substances.
- Include instructions when used for groups of patients considered to be particularly vulnerable to such substances.
- Maintain the online database of UDIs.
How ComplyMarket can help you:
- ComplyDoC: is an intelligent IT solution and the first open source cloud solution for supply chain sustainability, chemical and product compliance management to collect information from suppliers.
- Ad hoc consultancy: The ComplyMarket team has extensive experience in providing regulatory support to the Medical Device Regulation "MDR".