Balance risk and benefit: the manufacturer's obligations for dangerous substances in medical devices and as complymarket can simplify compliance
The regulation on medical devices (EU) 2017/745 ("MDR") requires the regulation of the substances that are carcinogenic, mutagenas or toxic for reproduction (cmr) and/or endocrine disturbing substances in medical devices. This article provides an overview of the regulations for CMR and/or disturbing endocrine substances in medical devices and the manufacturer's obligations if exceeded the 0.1%threshold.
Products in question:
Devices, or parts of them or materials used in them, that:
- they are invasive and come into direct contact with the human body,
- (re) administer drugs, body fluids or other substances, including gases, from/to body, or
- They transport or retain these drugs, body liquids or substances, including gases, from (re) administer to the body.
Regulations:
- Medical devices must not contain cmr and/or disturbing endocrine substances in a concentration higher than 0.1% by weight/weight (W/W)/components.
- Medical devices must not contain substances that are carcinogenic, mutagen or toxic for reproduction ('CMR'), of category 1A or 1b, in accordance with part 3 of Annex VI of the CLP regulation (EC) n. 1272/2008, or substances defined as disturbing endocrine according to article 59 of the Reach regulation (EC) no. 1907/2006 and article 5 (3) of the Biocidal Product Regulations (EU) n. 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.
- Landing on the presence of these substances on the device itself and/or packaging for each unit or, if appropriate, on the packaging, with the list of these substances.
- Include instructions if used for groups of patients considered particularly vulnerable to these substances.
- Keep the UDI online database.
As complymarket it can help you:
- ComplyDoc:It is an intelligent IT solution and the first cloud solution with an open source code for the sustainability of the supply chain, the management of chemical compliance and products to collect information from suppliers.
- Ad hoc consultancy: the complymarket team has vast experience in providing regulatory support to the regulation on "MDR" medical devices.