11
Jun
Medical devices and in-vitro medical devices: News and forthcoming provisions
In recent days there have been developments in the regulatory framework for medical devices and in-vitro medical devices via the proposal of the European Commission for the amendment of the MDR and the IVDR and the new guidance of the MDCG.
16
Jan
Software medical devices in combination with hardware: The new MDCG guidelines
Medical device softwares (“MDSW”) that work in combination with hardware or hardware components to achieve their medical purposes: this is the topic of the guidelines issued by the MDCG-4, addressing manufacturers directly in an effort to provide regulatory guidance.
14
Sep 23
The AI Act: What will the impact be on the medical device industry?
The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
12
Sep 23
Clinical investigation of medical devices: implementation rules set out in Italy
In Italy, the process of establishing national regulations for clinical investigation of medical devices continues: in June, four new decrees were published, dealing with the modalities for submitting clinical investigation applications and communications according to the national procedure.
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to July 31st.
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to July 31st.
