As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field of post-market surveillance and of these new requirements is related

Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called “passive” methods of post-market surveillance activities, as basically the manufacturer does

The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. The requirements

One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is

The PMCF - Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements related post-market clinical follow-up plan and report have been further