Within the new UE 2017/745 (MDR) regulatory framework for medical devices, the evaluation of the degree of percutaneous absorption is required for the classification of substance-based medical devices.
A strong rationale supporting the design of absorption studies and its results allows manufacturer to support the correct placement of their product as a medical device and its classification in an appropriate category.
The skin or mucosae models employed by our laboratories are derived from a human source and include in vitro reconstructed 3D tissues (epidermis + derma, damaged skin, vaginal, oral or gingival mucosae, etc.) or ex vivo tissue (skin from surgical procedures). In specific cases, such as for comparative evaluations or screenings, the use of synthetic membranes simulating the human skin and its thickness, composition and properties is also possible.
Abich – Lifeanalytics, the Group’s Competence Center for the Pharmaceutical and Cosmetic sectors, developed and offered its customers substantial quality services for percutaneous absorption studies designed to verify the absorption profile of any type of product or formulation designed for contact with the skin or mucosae.
The regulation introduced the concept of substance-based medical devices and defined their classification according to the new rule 21 (annex VIII).
What does rule 21 imply
medical devices composed of substances or combinations of substances and that are intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed into the human body are classified as:
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