EUDAMED: the next deadline is already approaching. Are Manufacturers truly ready?
Starting from 28 May 2026, the Actor, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules became mandatory. For many…
Posts by Emanuele Bertino
PPWR – What changes for companies and how to prepare
On 12 August 2026, one of the first operational deadlines of Regulation (EU) 2025/40 (PPWR) will come into force. For…
From Complaint to Reporting: The New Operational Workflow of the Italian Ministry of Health
With Circular No. 59712 of 21 July 2026, the Italian Ministry of Health introduced a new digital system for managing…
Published the 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy
The 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy provides an updated snapshot of the…
Implantable devices and class III devices: Delegated Regulation (EU) 2026/1451
With the publication of Delegated Regulation (EU) 2026/1451, the European Commission expands the list of implantable devices and class III…
National HTA Medical Device Program (PNHTA‑MD) 2026–2028
Technological innovation must advance hand in hand with sustainability and clinical validation. This Focus examines the National HTA Programme for…
The ecosystem of medical device development: the strategic role of Early Feasibility Studies (EFS)
Within the complex and dynamic ecosystem of medical device development, innovation cannot advance without a solid and timely clinical strategy.…
AIFA 5% Fund: updated access criteria for orphan drugs and rare diseases
The Italian Medicines Agency (AIFA) has published an update on the access criteria for the AIFA 5% Fund, established by…
Dialogue with the CSE: modalities and procedures for hearings
AIFA has published the procedures for requesting a hearing before the Scientific and Economic Commission for Medicines (CSE). Companies, scientific…
AIFA Independent Research Call 2025
The Italian Medicines Agency (AIFA) has published the second call for Independent Research, an initiative aimed at supporting pharmacological interventional…