The new MDR medical device regulation 2017-745 makes it very clear in appendix I (General safety and performance requirements) in chapter II concerning the requirements relating to the design and manufacture of medical devices, that attention particular attention must be paid, for example, to the choice of materials, their intrinsic properties, their biocompatibility, etc.
Point 10.4 specifically concerns substances in order to reduce the risks associated with their use. In paragraph two of point 10.4.1, the infusion devices are particularly targeted.
Devices, or parts of devices or materials used that:
contain the following substances in a concentration greater than 0.1% by mass fraction (m / m) only when justified, in accordance with section 10.4.2:
The committee’s mandate provides for at least a benefit / risk assessment of the presence of phthalates belonging to one of the groups of substances referred to in section 10.4.1, points a) and b). The benefit / risk assessment takes into account the destination and the context in which the device is used, as well as the substances and materials and the alternative medical designs and / or treatments available.
For ten years, for Phthalates (in particular DEHP), then more recently for Bisphenol A, Didactic, thanks to a sustained regulatory watch, has initiated a fundamental approach to limit the exposure of patients and caregivers to CMR substances and endocrine disruptors. This commitment and this work led to the marketing under the Infineed brand of the DEHP-free and Bisphenol A “Gravity 5.5” infusion line in 2019.
Thus the Gravity 5.5 infuser was born.
In its 3-way versions, it has its characteristic green tap to facilitate its identification.
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