New FAQ on the European Medical Device Nomenclature (EMDN) to support the EUDAMED
The Medical Device Coordination Group (MDCG), composed of representatives of all Member States and a representative of the European Commission, endorsed a new FAQ on the European Medical Device Nomenclature (EMDN)
Mutual recognition for medical devices between the EU and Switzerland ceased to apply on 26 May 2021: what is the impact for the sector?
Interview to Anna Gottret, Alisa Burkhard and Sophie Winkler of Flying Lawyers, Zurich
European Health Union: Commission publishes open public consultation on the European Health Data Space
Italian Competition Authority approves two emergency cooperation projects: one for joint distribution of surgical masks and one common moratorium scheme on consumer lending
On May 27, 2020, for the first time the Italian Competition Authority (“AGCM”) applied its communication on cooperation agreements in the context of the COVID-19 emergency (“Italian Communication”), applicable since April 24, 2020.
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.
Medical Devices Regulation: European Commission adopted a proposal to postpone the date of application of the MDR by one year, until 26 May 2021