Aim of the Group
The Group on Medical Devices was born in October 2008 with the following aims:
To examine in depth the knowledge of regulatory requirements applicable to Medical Devices and to point out the differences between European laws and non-European laws. To evaluate current regulation in the Medical Device Area; to point out the updates and to analyse the set of problems raising on its practical application. To analyse the procedures for the authorisation and management of Clinical Trials with Medical Devices.
To promote academic plan of actions to encourage the approch to the Medical Devices by manufacturing Industries and CROs interested in increasing the development of the relevant area.
Organisation of the Group
The Group mainly acts by means the followig activities:
To set up project groups devoted toexamine in depth specific themes.
Participation/Organisation of educational events to make known, analyse and promote debates among participants regarding relevant matters on regulation or practical aspetcs of single procedures.
Activities of the Group
Since 8th of October 2008, first meeting in Rome, the number and complexity of the themes to be covered have been clear.
At this purpose, it was defined to set up subgroups, each of them progressively provided with a matter or a theme to examine in depth.
In addition, two meetings per year were defined to be in place with the aim to share the activities conducted inside the groups, to decide the way of results’ distribution and to agree upon the following steps. During the above meetings, experts on the relevant topics are periodically invited to analyse a specific aspect of the regulation or a certain matter.
Following the activities of the working subgroups, a database has been published on SIMeF/Working Groups/Medical Devices on Normativa nazionale generale, Normativa classificazione, Normativa nazionale sperimentazioni cliniche, Normativa nazionale vigilanza, Segnalazioni, Normativa nazionale prezzi, Normativa internazionale, Linee guida ISO. The above documents are associated with Synopses aimed to facilitate orientation inside the numbers of national and international laws and legislations together with adverse events/adverse reaction report forms for Medical Devices in a number of contexts.
The Database is updated on a regular basis.
Events 2015 - 2016
- Article published on SIMeFoggi, April 2015 “ The VII National Conference on Medical Devices. To guarantee efficacy, safety and innovation for a sustainable growing”.
- Article published on SIMeFoggi, December 2015 “Medical Devices: “Class I, the ones neglected”.
- SIMeF Seminar by Medical Devices Working Group on Medical Devices. Milan, December 2015 “ Clinical Surveys during development and life-cycle of a Medical Device”.
- Article published on SIMeFoggi, February 2016: “Clinical Surveys in development and life-cycle of the Medical Device”.
- Article published on SIMeFoggi, August 2016 :”Medical Devices and Medical–Diagnostic Devices in vitro: the two new Regulations are at final acts”.
- Article published on SIMeFoggi, December 2016: “Medical Devices post- marketing surveillance in Italy: a synopsis”.
- SIMeF Seminar by Medical Devices Working Group on Ministerial Decrees, December 2016: “Development and Planning, key elements for placing on the market of a Medical Device”.