Medical Devices Regulation

Balance of Risk and Benefit: Manufacturer Obligations for Hazardous Substances in Medical Devices and How ComplyMarket Can Simplify Compliance

The EU Medical Devices Regulation (EU) 2017/745 ("MDR") requires the regulation of carcinogens, mutagens or reproductive toxic (CMR) and/or endocrine disrupting substances in medical devices. This article describes the regulations for CMR and/or endocrine disruptors in medical devices and the manufacturer's obligations when the 0.1% threshold is exceeded.

Covered Products:

Devices or parts thereof or the materials used in them, namely:

• It is invasive, in direct contact with the human body,
• (re)administer drugs, body fluids or other substances, including gases, in relation to the body,
• It transports or stores related drugs, body fluids or substances, including gases, for (re)administration into the body.

Regulations:                

• Medical devices may not contain CMR and/or endocrine disruptors up to 0.1 wt-to-weight (w/w)/components.
• Medical devices must not comply with Category 1A or 1B with endocrine disruptors defined in Part 3 of Annex VI of CLP Regulation (EC) No 1272/2008 or Article 59 of REACH Regulation (EC) No 1907/2006 and Article 5(3) of the biocidal products Regulation (EU) No 528/2012.

Manufacturer Obligations:

If the 0.1% wt-to-weight (w/w) threshold is exceeded, the manufacturer must:

• Carry out a benefit-risk assessment and indicate the rationale in the technical dossier.
• Mark the presence of such substances by listing them on the appliance itself and/or on the packaging for each unit or, if appropriate, on the sales packaging.
• It includes instructions for use for those groups of patients who are considered particularly sensitive to such substances.
• Maintain the UDI Online Database.

How ComplyMarket Can Help:

• ComplyDoC: It is an ingenious IT and the first open-source cloud solution for supply chain sustainability, chemical and product compliance management, collecting information from suppliersChina.
• Ad-hoc consultancy: The ComplyMarket team has extensive experience in providing regulatory support for the Medical Devices Regulation "MDR".