On 27 May 2026, the obligation of notification into the Spanish database CCPS (Comunicación de comercialización de Productos Sanitarios) ceased...
The effective application of Regulation (EU) 2017/745 (MDR) determined a deep change in the European regulatory framework of medical devices,...
28 May 2026 is now close, and so is the mandatory use of the EUDAMED modules “UDI/devices” and” notified bodies...
The European Medicine Agency (EMA) has announced the start of a new pilot program dedicated to the so called “Breakthrough...
A distributor, an importer or any other subject making any change in a product already put on the market may,...
On 13 February 2026, Decree 29 December 2025 was published in the Official Journal of the Italian Republic, including the...
EUDAMED, the unique database of medical devices, introduced by the European Commission, is slowly finding its final form, thus leading...
Just a few days ago, the Medicines & Healthcare products Regulatory Agency (MHRA) published a new guidance document titled “Preparing...
The latest update of the Ministry of Health guideline on MD, IVD and PMC (Presidi Medico Chirurgici, medical surgical aids)...
In the complex regulation landscape of medical devices (MDs) and in vitro diagnostics (IVDs), regulatory assistance represents a crucial element...