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.
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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17
Nov 21
Preliminary guidance on the requirements and provisions of the MDR applicable to legacy devices
The devices known as “legacy devices” should be subject to the application of only some of the provisions and requirements set forth by the MDR, as better clarified and identified by the Medical Device Coordination Group report issued on October 21, 2021 (“MDCG 2021-25”).
15
Nov 21
AGCM finds no abuse in diagnostic imaging device manufacturers’ refusal to provide downstream competitors access to information for maintenance services
On March 30, 2021, the Italian Competition Authority closed an investigation it had opened in 2018 against three manufacturers of high-end diagnostic imaging devices.
<!--:it-->The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices<!--:-->
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
