Organizing medical devices

تنظيم أجهزة الطبية

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".

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