Compliance Espresso
Il podcast sulla legislazione europea sui dispositivi medici.
The podcast on european legislation on medical devices.
Compliance Espresso
Latest Episodes
Regulation 2026/977: a missed opportunity!
The episode takes a critical look at Regulation (EU) 2026/977, published on May 5, which introduces uniform and rigid timelines for the conformity assessment activities of Notified Bodies—for example, the review of the technical documenta...
Il Regolamento 2026/977: un'occasione persa!
La puntata commenta criticamente il Regolamento (UE) 2026/977, pubblicato il 5 maggio, che introduce tempistiche uniformi e rigide per le attività degli Organismi Notificati nella valutazione della conformità, ad esempio l’analisi del fas...
The Birth of the CE Marking
The CE marking originated indirectly from a dispute over the French liqueur Crème de cassis. In 1979, Germany blocked its import because its alcohol content was lower than the national requirement for liqueurs. The importer appealed to the Euro...