Medical Device Regulations

>Offsetting the Risks and Benefits: Manufacturers' Obligations to Hazardous Substances in Medical Devices, and How ComplyMarket Can Simplify Compliance

Medical Device Regulation (EU) 2017/745 ("MDR") requires the regulation of substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) and/or endocrine disruptors in medical devices. This article provides an overview of the regulations for CMR and/or endocrine disruptors in medical devices, along with the manufacturer's obligations if the 0.1% threshold is exceeded.

Intended Product:

Device, or part of a device, or material used therein, which:

• It is invasive and directly in contact with the human body,
• (Re)administer drugs, bodily fluids, or other substances, including gases, to/destinations from/the body, or
• Transport or store drugs, bodily fluids, or substances, including gases, to (re)administer to the body.

Regulation:

• Medical devices must not contain CMR substances and/or endocrine disruptors in concentrations above 0.1% weight per weight (w/w)/component.
• Medical devices must not contain substances that are carcinogenic, mutagenic, or toxic to reproduction ('CMR'), category 1A or 1B, in accordance with Part 3 of Annex VI of CLP Regulation (EC) No 1272/2008, or substances designated as endocrine disruptors in accordance with Article 59 of the REACH Regulation (EC) No 1907/2006 and Article 5(3) of the biocidal products (EU) Regulation No 528/2012.

Manufacturer's Liability:

If the 0.1% w/w threshold is exceeded, the manufacturer should:

• Conduct a benefit-risk evaluation and include justification in the technical file.
• Mark 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 a list of such substances.
• Include instructions for use for a group of patients considered susceptible to the substance.
• Maintaining UDI Online Database.

How ComplyMarket Can Help You:

• ComplyDoC: An intelligent and first open-source cloud solution for Supply Chain Sustainability, Product & Chemical Compliance Management to collect information from suppliers.
• Ad-hoc Consulting: The ComplyMarket team has extensive experience in providing regulatory support for the Medical Device Regulation "MDR".