Medical Device Regulation

Balancing risk and benefit: Manufacturer's obligations for hazardous substances in medical devices and how ComplyMarket can simplify compliance

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

Subject Products:

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

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

Normative:

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

• Carry out a risk-benefit assessment and justify it in the technical file.
  
• Label 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 the list of such substances.
  
• Include instructions when used for groups of patients considered to be particularly vulnerable to such substances.
  
• Maintain the online database of UDIs.

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 consultancy: The ComplyMarket team has extensive experience in providing regulatory support to the Medical Device Regulation "MDR".