Регулиране на медицински изделия

Balancing Risk and Benefit: The Manufacturer's Obligations for Hazardous Substances in Medical Devices, and How ComplyMarket Can Streamline Compliance

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

Products in Scope:

Devices, or those parts thereof or those materials used therein, that:

• are invasive and come into direct contact with the human body,
• (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
• transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.

Regulations:

• Medical devices shall not contain CMR and/or endocrine-disrupting substances in a concentration above 0.1% weight by weight (w/w)/components.
• Medical devices shall not contain substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to CLP Regulation (EC) No 1272/2008, or endocrine-disrupting defined substances according to Article 59 of REACH Regulation (EC) No 1907/2006 and Article 5(3) of biocidal products Regulation (EU) No 528/2012.

Manufacturer's Obligations:

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

• Carry out a benefit-risk assessment and draw the justification in the technical file.
• Label the presence of such substances on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
• Include instructions if use for patient groups considered particularly vulnerable to such substances.
• Maintain UDI Online Database.

How ComplyMarket can help you:

• ComplyDoC: is an intelligent IT and first ever open source code cloud solution for Supply Chain sustainability, chemical & product compliance Management to collect information from suppliers.
• Ad-hoc consulting: ComplyMarket team has extensive experience in providing regulatory support to Medical Devices Regulation “MDR”.