Medical Devices Regulation

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

The Medical Devices Regulation (EU) 2017/745 ("MDR") mandates the regulation of carcinogenic, mutagenic or toxic for reproduction (CMR) substances 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.

Affected products:

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

• are invasive and come into direct contact with the human body,
• (re-administer) medicines, bodily fluids or other substances, including gases, to/from the body, or
• carry or store such drugs, bodily 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 greater than 0.1% by weight/weight (w/w)/components.
  
• Medical devices must not contain substances that are carcinogenic, mutagenic or toxic for reproduction ('CMR'), category 1A or 1B, in accordance with Part 3 of Annex VI to the CLP Regulation (EC) No 1272/2008, or substances defined as endocrine disruptors according to Article 59 of the REACH Regulation (EC) No 1907/2006 and Article 5( (3) of the Biocidal Products Regulation (EU) No 528/2012.

Manufacturer's obligations:

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

• Perform a benefit-risk assessment and justify this in the technical file.
  
• Label the presence of such substances on the device itself and/or on the packaging for each unit or, if applicable, on the sales packaging, with the list of these substances.
  
• Include instructions when used for groups of patients considered to be particularly vulnerable to such substances.
  
• Maintain the online database of IDUs.

How ComplyMarket can help you:

• ComplyDoC: is an intelligent IT solution and the first open-source cloud solution for supply chain sustainability, chemical and product compliance management to collect Information from suppliers.
  
• Ad-hoc consultation: The ComplyMarket team has extensive experience in providing regulatory support to the Medical Devices Regulation "MDR".