Regulation of medical devices

Balancing risks and benefits: obligations of the manufacturer of <span dir="LTR"> CMR in medical devices, and how to ComplyMarket  Simplify compliance

requires regulation of medical devices (MDR) EU 2017/745 ("MDR") regulation of substances that are carcinogenic, transgenic or toxic to reproduction (CMR) and/or endocrine-impairing substances in medical devices. This article provides an overview of regulations related to substances CMR and/or endocrine obstruction of medical devices, and the obligations incurred by the manufacturer if the limit of 0.1% is exceeded.

products in the range of vision:

devices, parts thereof or materials used therein, which:

·          be invasive and interact directly with the human body,

·          (Re)administering medicines, bodily fluids or other substances, including gases, to/from the body, or

·          Transporting or storing such medicines, bodily fluids or substances, including gases, to be (re)administered to the body.

Organizations:

·          Medical devices may not contain substances CMR and/or endocrine obstruction at a concentration of more than 0.1% by weight (w/w)/ingredients.

·          Medical devices may not contain substances that are carcinogenic, genetically mutated or toxic to reproduction ("CMR"), category 1A or 1B, in accordance with Part 3 of Annex VI to regulate CLP (EC) No 1272/2008, endocrine obstructive substances as defined in Article 59 of the regulation REACH (EC) No 1907/2006 and article 5(3) of the Regulation of Deadly Biological Products (EU) No 528/2012.

manufacturer's obligations:

if exceeds the limit of 0.1% w/w, the manufacturer<span dir="LTR"> must:

·          Conduct a risk-benefit assessment and provide justification in the technical dossier.

·          Mark the presence of such substances on the device itself and/or on the packaging per unit or, where appropriate, on packaging for sale, with a list of such materials dir="LTR">.

·          Include instructions if used for groups of patients considered particularly vulnerable to these substances.

·          Maintain an online unique identity database.

How can <span dir="LTR"> ComplyMarket Help you:

·           : ComplyDoCIt is a smart IT solution and is the first open source software cloud solution for supply chain sustainability and chemical product compliance management to collect information from suppliers.

·          Customized consulting: Owns ComplyMarket Extensive experience in providing regulatory support for the regulation of medical devices "MDR".