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...
Whoever deals with medical device, has to face this question sooner or later: what is ISO 13485? It is an...
In the latest years, the sector of medical devices (MD) and in vitro diagnostics (IVD) underwent important regulatory and organisation...
On 5 May 2025 the European Commission published the updated version of the MIR form (v7.3.1), used by manufacturers to...
In the current health digitalisation context, many app developers and companies of the healthcare sector ask themselves if their software...