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

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

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

The concept of custom-made devices is surely not new and many competent authorities have specific requirements in place to regulate the manufacture and distribution of these types of medical devices.

Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product characteristics; in this context GSPRs (General safety and performance requirements),