POSITION STATEMENT Aesthetic Medicine and Surgery Medical Device Classification

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about Aesthetic Medicine and Surgery Medical Device Classification promote from Many Scientific Society about the possibile problem of Reg. (EU) 2017/745 (MDR - Medical Device)
more info and complete document-> www.collegiomedicinaestetica.it


1.     To eliminate the product groups referred to under points 2/3/4/5 from the list of products without medical purposes, hence restoring the current configuration and thus ensuring greater safety for patients and operators, providing that the devices placed on the market meet the requirements of the Regulation without any further element distorting the regulatory rationale.

2.     In the alternative to the above, should it not possible to modify the Annex of the Regulation, a specific classification in the Annexes for medical devices referred to in points 2/3/4/5 of Annex No. 16 should be promoted, which differ from the products to be exclusively used by a doctor as they refer to the basic Regulation. The Annexes should therefore feature only the products whose use is made by a doctor.

3.     To involve the representatives and technicians of the reference medical class in working groups aimed at drafting, approving and revising the Annexes by involving the representatives of the signatory scientific societies representing the doctors of this sector on the European territory.

4.     To ensure the development of any Annexes based on the support of representatives of the scientific field referred to under point 3 above and with working methods aimed at highlighting conclusions based on EBM, as well as on evaluations and bibliometric indices constituting an international reference point.