A question and answer document has been published by the European Commission, the purpose of which is to facilitate the application of Regulation (EU) 2023/607 The main objective of the European Medical Device Regulation (MDR) 2017/745 is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of…
Gruppo FarmaImpresa is among the first Italian companies to obtain MDR certifications for some of its substance-based medical devices As a reminder, the new Regulation (EU) 2017/745 or MDR (Medical Device Regulation) is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place…
The new Regulation (EU) 2017/745 or MDR is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place a medical device on the European market. The new Regulation complements and replaces the previous Directives 90/385/EEC and 93/42/EEC, providing more stringent requirements and measures…
Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.…