13
Dec 19
News about advertising medical devices on Facebook: updates from the Ministry of Health
On October 24, 2019, the Ministry of Health published an addendum to the guidelines on the advertising of medical devices, in vitro diagnostic medical devices and medical-surgical devices (collectively “Medical Devices” or “MD”) on Facebook (the “Guidelines”).
12
Dec 19
New European Guidance on the qualification and classification of software as medical devices
In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”).
4
Dec 19
Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives
On May 26, 2020, the new Medical Device Regulation 2017/745/EU (“MDR”) will enter into force.
6
Jun 19
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.
8
Apr 19
Paper on new governance procedures for medical devices in Italy
On March 22, 2019, the Italian Ministry of Health published a document outlining the new governance procedures for medical devices that the Government intends to implement in Italy.
6
Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
