Medical Device Regulations

Balancing Risks and Benefits: 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 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 parts thereof or materials used therein, which:

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

Regulations:

• Medical devices must 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 to reproduction ('CMR'), category 1A or 1B, in accordance with Part 3 of Annex VI to CLP Regulation (EC) No 1272/2008, or substances defined as endocrine disruptors according to Article 59 of 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 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, where appropriate, on the retail packaging, with the list of such substances.
  
• Include instructions if used for patient groups considered particularly vulnerable to such substances.
  
• Maintain the UDI Online Database.

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