The need to disclose the composition of medical devices at the European level

Herman, Anne;Goossens, An
(2019) Contact Dermatitis — Vol. 81, n° 3, p. 159-160 (2019)

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(en) A medical device (MD) is any instrument, equipment, material, or product intended to be used in humans for medical purposes, the main action of which is not obtained by pharmacological or immunological means. Hence, there are a very large number of MDs, ranging from simple contact lenses and sticking plasters to sophisticated pacemakers. They are classified into four categories (I, IIa, IIb, and III) according to their risk level, which is based on several criteria, including indications, invasiveness, duration of use (<1 hour, ≤ 30 days, > 30 days), and implantability, but also the risk related to the patient. Although there is no doubt that MDs have greatly contributed to improve the quality of clinical care, they are able to sensitize and provoke allergic contact dermatitis (ACD). [...]
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Herman, A., & Goossens, A. (2019). The need to disclose the composition of medical devices at the European level. Contact Dermatitis, 81(3), 159-160. https://doi.org/10.1111/cod.13354 (Original work published 2019)