Class I medical device manufacturers may benefit from the transitional period under the MDR
On December 17, a corrigendum to Medical Device Regulation (MDR) 745/2017 was approved by the European Parliament that allows certain devices classified in Class I under Directive 93/42/EEC to benefit from the transitional period provided by the MDR.
EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation
In November 2019, the European Commission published a draft version of the answers to the numerous questions (“Q&A”) raised by stakeholders relating to the implementation of the rules laid down in Regulation (EU) No. 536/2014 on clinical trials.
Regional Administrative Court of Tuscany: recent judgment on biosimilars
n November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – “T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.
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”).
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
In its decision issued on 3 July 2019 in Viridis, Case C-668/17 (the “Decision”), the Court of Justice of the European Union (“CJEU”) ruled that the lengthy time necessary to complete a clinical drug trial is not a proper reason to prevent the prematurely registered trademark from being revoked for non-use.
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”).