Balancing risks and benefits: Duties of manufacturers on hazardous substances in medical devices, and how compliesMarket can simplify compliance
Medical device (EU) 2017/745 ("MDR") requires control of carcinogenic, mutagenic or toxic substances (CMR) and/or endocrine troublemakers in medical devices. This article provides an overview of the regulation of the CMR substance and/or endocrine troublemakers in medical devices, and the manufacturer's obligation if the threshold is 0.1%.
Product covered:
The device, or part of the device, or material used in it, which:
- Be invasive and directly in contact with the human body,
- (Mem) give medication, body fluids or other substances, including gas, to/from the body, or
- Transport or store medications, body fluids or substances, including gas, to (mem) give back to the body.
Regulation:
- Medical devices should not contain CMR and/or endocrine troublemakers in concentrations exceeding 0.1% weight to weight (W/W)/components.
- Medical devices cannot contain carcinogenic, mutagenic or toxic substances ('CMR'), category 1A or 1B, in accordance with Part 3 of Appendix VI to CLP (EC) No. 1272/2008, or substances defined as endocrine trouble in accordance (EU) No 528/2012.
Manufacturer's obligation:
If the threshold of 0.1% w/w is over, the manufacturer must:
- Performs the Benefits of Benefits and expresses justifications in the technical files.
- Label the presence of the substance on the device itself and/or on the packaging for each unit or, if appropriate, on the sale packing, with the list of the substance.
- Includes instructions if used for a group of patients who are considered very vulnerable to the substance.
- Maintain an online database online.
How ComlyMarket can help you:
- Complydoc:Cloud Solutions Open and Smart Source Code for Sustainability Supply Chain, Chemical Compliance Management & Products to collect information from suppliers.
- AD-HOC Consultation: The Comlymarket team has extensive experience in providing regulation support to the "MDR" medical device regulation.