Balancing risks and benefits: manufacturer's obligations for hazardous substances on medical devices, and how compliamarket can simplify compliance
The Medical Devices Regulation (EU) 2017/745 ("MDR") requires the regulation of substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) and/or endocrine disturbing substances on medical devices. This article provides an overview of the regulations for CMR substances and/or endocrine disturbing on medical devices, and the manufacturer's obligations if the threshold of 0.1%is exceeded.
Products in scope:
Devices, or parts of the same or materials used in them, which:
- They are invasive and come into direct contact with the human body,
- (manage again) medicines, bodily liquids or other substances, including gases, to/from the body, or
- They transport or store such medications, body fluids or substances, including gases, to be (re) administered to the body.
Regulations:
- Medical devices should not contain CMR and/or endocrine disturbance substances in a concentration of more than 0.1% by weight/weight (w/w)/components.
- Medical devices should not contain substances that are carcin, mutagenic or toxic for reproduction ('cmr'), category 1a or 1b, in accordance with Part 3 of Annex VI of the CLP (CE) Regulation No. 1272/2008, or substances defined as endocrine disturbing according to article 59 of the Reach Regulation (EC) No 1907/2006 and Article 5 (3) of the Regulation of biocidal products (EU) No 528/2012.
Manufacturer's obligations:
If the 0.1% W/W threshold is exceeded, the manufacturer must:
- Perform an evaluation of risks and benefits and justify it in the Technical Archive.
- Label the presence of such substances in the device itself and/or in the packaging for each unit or, when appropriate, in the sales packaging, with the list of such substances.
- Include instructions if used for groups of patients considered particularly vulnerable to such substances.
- Maintain the UDI online database.
How Comleymarket can help you:
- Complydoc:It is a smart solution of IT and the first solution in the open source cloud for the sustainability of the supply chain, the management of chemical compliance and products to collect information from suppliers.
- AD-HOC Consulting: The compliamarket team has extensive experience in providing regulatory support to the "MDR" medical device regulations.