4
Feb 22
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
4
Feb 22
Pharmacies managed by corporations and incompatibility with the exercise of the medical profession: Recent positions of the administrative courts
Administrative jurisprudence recently took up the issue of incompatibility between the management of a pharmacy and the performance of other activities in the health sector, as established by Article 7 of Law No. 362/1991.
3
Feb 22
Italian Competition Authority confirms its approach to RPM in a recent investigation into a manufacturer of products sold in pharmacies (probiotics)
In May 2021, the Italian Competition Authority (AGCM or ICA) launched an investigation into restrictions on resale prices that a pharmaceutical company, SOFAR, was alleged to have imposed upon its distribution network for a probiotic product (Enterolactis Plus).
14
Jan 22
Medical devices and artificial intelligence: FDA issues first guidelines for developing Good Machine Learning Practices
On October 27, 2021, the U.S. FDA, in collaboration with the Canadian regulatory agency, Health Canada, and the United Kingdom’s MHRA, released a document containing 10 guiding principles to promote the development of Good Machine Learning Practice.
