Achieving a balance between risks and benefits: the company's manufacturer's obligationsCMRIn medical devices, and how canComplymark Simplify compliance
It requires the organization of medical devices(MDR)European Union 2017/745("MDR")Organizing materials that are carcinogenic, genetically transformed or toxic to reproduce(CMR)And/or substances that hinder endocrine glands in medical devices. This article provides an overview of organizations related to materialsCMRAnd/or obstructing the endocrine glands in the medical devices, and the obligations that the manufacturer bears in the event that the extent exceeds 0.1%.
Products in the range of vision:
Devices, parts of them or materials used in them, which:
· Be invasive and interact directly with the human body,
· (Re -giving medications, physical fluids or other substances, including gases, to/from the body, or
· Transfer or storage such as medications, physical fluids or substances, including gases, to be (re -given) to the body.
Organizations:
· Medical devices may not contain materialsCMRAnd/or obstructing the endocrine with a concentration of more than 0.1% by weight(W/w)/the components.
· Medical devices may not contain carcinogenic, genetically or toxic substances for reproduction("CMR"), Category 1AOr 1B, According to Part 3 of the sixth facility to organizeCLP (EC) No 1272/2008, Or materials that hinder the endocrine as it is specified in Article 59 of the organizationReach (EC) No 1907/2006Article 5 (3) of the regulation of deadly biological products(Eu) No 528/2012.
Manufacturer obligations:
If the extent exceeds 0.1% w/w, The manufacturer must:
· Conduct an evaluation of risks and benefits and provide justification in the technical file.
· Putting a sign of the presence of such materials on the same device and/or on the packaging for each unit or, wherever it is appropriate, on the packaging for sale, with a list of these materials.
· Instructing instructions if they are used for patient groups considered special subject to these substances.
· Maintaining a unique identity database online.
How canComplymarkYour help:
· :ComprydocIt is an intelligent solution to information technology and is the first open -source cloud solution to the sustainability of supply chain and compliance with chemical products to collect information from suppliers.
· Consulting as needed: owns a teamComplymarkExtensive experience in providing organizational support for the regulation of medical devices"MDR".