Últimas Notícias
Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
For the purposes of the Framework, DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other...
Advancing regulatory science in the EU – mid-point report published
PUBLISHED BY EMA News 22/03/2023 EMA has published a reportsummarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human...
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 has been published today 20th Martch in the Official Journal of the EU and therefore entered into force today....