Balancing Risk and Benefit: Manufacturer's Obligations for Hazardous Substances in Medical Devices, and How ComplyMarket Can Simplify Compliance
The Medical Devices Regulation (EU) 2017/745 ("MDR") mandates the regulation of carcinogenic, mutagenic or toxic for reproduction (CMR) substances and/or endocrine disrupting substances in medical devices. This article provides an overview of the regulations for CMR and/or endocrine disrupting substances in medical devices, and the manufacturer's obligations if the 0.1% threshold is exceeded.
Affected products:
Devices, or parts or materials thereof used therein, that:
- are invasive and come into direct contact with the human body,
- (re-administer) medicines, bodily fluids or other substances, including gases, to/from the body, or
- carry or store such drugs, bodily fluids or substances, including gases, to be (re)administered to the body.
Regulations:
- 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 to 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 threshold of 0.1% w/w is exceeded, the manufacturer must:
- Perform a benefit-risk assessment and justify this in the technical file.
- Label the presence of such substances on the device itself and/or on the packaging for each unit or, if applicable, on the sales packaging, with the list of these substances.
- Include instructions when used for groups of patients considered to be particularly vulnerable to such substances.
- Maintain the online database of IDUs.
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 consultation: The ComplyMarket team has extensive experience in providing regulatory support to the Medical Devices Regulation "MDR".