Clinical trials Regulation: AIFA endorsed a proposal for the temporary administration of trials pursuant to the CTR, pending the publication and full implementation of the ministerial decrees on the reorganization of ethics committees and single tariff
The Regulation amending Regulation (EU) 2017/746 as regards new transitional provisions for certain IVDs and the deferred application of conditions for in-house devices has now been published
The Italian association of pharmaceutical companies published a new version of the Code of Professional Conduct, regulating relations between pharmaceutical companies and their relations with the scientific and healthcare sectors
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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.
15
Dec 21
New national guidelines on telerehabilitation
Last October, the State-Regions Conference approved a document submitted by the Ministry of Health containing national guidelines for the delivery of telerehabilitation services by healthcare professionals.
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
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