Medical Device Regulation

>Balancing Risks and Benefits: Manufacturers' Obligations to Hazardous Substances in Medical Devices, and How ComplyMarket Can Simplify Compliance

Medical Device Regulation (EU) 2017/745 ("MDR") requires the regulation of substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and/or endocrine disruptors 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.

Products Covered:

The device, or part of the device, or the material used therein, which:

• Invasive and in direct contact with the human body,
  
• (Me)administer medicines, bodily fluids or other substances, including gases, to/from the body, or
  
• Transporting or storing medications, bodily fluids, or substances, including gases, to ()give back to the body.

Regulation:

• Medical devices must not contain CMR and/or endocrine agonists in concentrations exceeding 0.1% weight to weight (w/w)/component.
  
• 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 in accordance with Article 59 of REACH Regulation (EC) No 1907/2006 and Article 5(3) of the Bioleft-handed (EU) Products Regulation No 528/2012.

Manufacturer's Obligations:

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

• Carry out a benefit-risk assessment and state justifications in technical files.
  
• 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 a list of such substances.
  
• Include instructions if used for a group of patients who are considered particularly susceptible to the substance.
  
• Keeping UDI Database Online.

How ComplyMarket Can Help You:

• ComplyDoC: An open-source and intelligent cloud solution for Supply Chain Sustainability, Chemical & 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".