News - 21/11/2019

In partnership with Confindustria Dispositivi Medici (Italian association of Medical Device Companies)

Florence – Fortezza da Basso
Friday 29 November
9 a.m. – 6:30 p.m.

Italian and European sector associations, national and international regulatory bodies as well as Members of the EU Parliament will gather for this international conference in the capital of Tuscany to discuss a strategic sector which is able to provide safe and effective bench-to-bedside solutions and is increasingly growing in terms of turnover, investments and professional job creation.

The event concerning Medical Devices Made of Substances will take place during the 14th Forum “Risk Management in Sanità” (Risk management in the healthcare sector), organised by the Istituto Superiore di Sanità (the Italian National Institute of Health) and the Foundation Fondazione Sicurezza in Sanità (Safety in the healthcare sector). It is sponsored by the Italian Ministry of the Environment, the Region of Tuscany, the Conferenza delle Regioni e delle P.A. (Association of Italian Regions and Autonomous Provinces), Agenas (the Italian National Agency for Regional Healthcare Services) and AIFA (Italian Medicines Agency).

The event will also be available in live streaming at the following website, with a simultaneous translation into English provided:
Live streaming

The event will take place in Florence, on Friday, 29th November, from 9 a.m. to 6:30 p.m. at the Fortezza da Basso (Porta alle Carre, Padiglione Spadolini, ground floor). The event is promoted by Confindustria Dispositivi Medici during the 14th Forum “Risk Management in Sanità”. The aim of the event is to foster a discussion on Medical Devices Made of Substances, involving regulatory and political authorities, as well as the industrial and healthcare sector. This event is becoming more and more important given the upcoming implementation of the new EU Regulation 745/2017, which is expected in May 2020.

The Medical Devices Made of Substances sector is the result of the latest scientific and technological innovation and includes therapeutic products with physiological, and thus non-pharmacological mechanisms of action, which therefore cannot be classified as medicinal products.

Rapidly affirming themselves as valuable therapeutic tools, these products fall within a European regulatory framework that is profoundly changing the self-medication sector, a framework that recognises and allows for the use of complex substances (and especially complex natural substances) in an allopathic context according to Systems Medicine criteria.

The event will be divided into three sessions, during which highly prominent figures from the industry associations, public administration and European and national politics will shed light on three different topics: implementation of EU Regulation 745/2017, the Industry’s perspective and the fiscal framework and customs classification of medical devices. A representative of the Argentinian Medicines Agency (ANMAT) will also be attending the event. This agency believes that the new EU Regulation can also be a source of innovation for the Argentinian pharmaceutical and healthcare system.

The first session on the implementation of the new Regulation will focus on the importance of the balance between ensuring safety and efficacy while preserving the innovation offered by this sector. Furthermore, the need to implement the Regulation according to the very latest research will also be highlighted. This process will involve European regulatory bodies, the Member States as well as notified bodies.

The second session will focus on the importance of the Medical Devices Made of Substances Sector for the international and European healthcare system, both in terms of the innovative therapeutic solutions which it is able to offer and in industrial terms. In fact, sales and investments are growing rapidly in this sector and highly professional job roles are being created.

Finally, the last session will focus on the correct fiscal and customs classification of Medical Devices Made of Substances. In this sector too, Italy offers a regulatory framework which allows fiscal issues to be correctly interpreted in compliance with the European criteria.