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
15
Sep 21
Compulsory licenses: Italy takes a step forward with the new article 70-bis of the industrial property code
Law Decree No. 77 of 31 May 2021 introduced into the Italian Industrial Property Code Article 70-bis on compulsory licenses for medicinal products and medical devices in case of declaration of a state of emergency
