MDCG 2022-21: Requirements for Preparation of the Periodic Safety Update Reports
The long awaited MDCG 2022-21 has been finally published and preparation of the Periodic Safety Update Report became much easier.…
Trend Reporting According to EU MDR and IVDR
In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the…
Field Safety Notice: What do you Need to Know?
Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers…
Field Safety Corrective Actions : EU MDR Requirements
Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related…
Complaint Handling Process for Medical Device Manufacturers
The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. Surely, compliant process is directly…
Summary of Safety and Clinical Performance (SSCP) according to EU MDR
As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field…
Vigilance Reporting Requirements according to EU MDR 2017/745
Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called…
Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the…
The PMCF (Post-Market Clinical Follow-Up) according to EU MDR 2017/745
The PMCF – Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements…
Post-Market Surveillance for EU MDR
New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with…