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
Article 61 of EU MDR: An Overview
In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains to Clinical Evaluation. At QualityMedDev website, we have previously explored
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
ISO 17511: Metrological Traceability for IVD Medical Devices
Recently, a new version of ISO 17511 has been published, bringing forth updated requirements for ensuring metrological traceability in In-vitro Diagnostic Medical Devices (IVDs). Within the realm of IVD devices,
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
