Medical Device Lifetime: An Overview
The Integral Role of Lifetime in Medical Device Utilization The lifetime of a medical device is a critical period during which the tool must safely and reliably perform its intended function.
MDR Extension According to Regulation 2023/607
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation
Reprocess of Single Use Devices: EU MDR Requirements
Article 17 of the EU MDR 2017/745 provides comprehensive guidelines regarding the requirements for the reprocessing of single-use devices. The significance of these requirements has been widely acknowledged, and numerous
Systems and Procedure Packs according to Article 22 of EU MDR
The requirements pertaining to system and procedure packs can be found in Article 22 of EU MDR 2017/745. This article aims to shed light on the key requirements concerning the
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 EU Medical Device Regulation (MDR) and Article 83 of the