Medical Devices Regulation

Medical Devices Regulation

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”.

ComplyMarket is a Total Compliance Solutions provider, using the power of AI to identify compliance requirements and perform risk assessments. Our expertise extends to the development of the first-ever open-source software designed specifically for supply chain management. This groundbreaking tool enables the efficient collection of compliance and sustainability information from suppliers, empowering our clients to uphold the highest standards of regulatory compliance and environmental stewardship.