Newsletters
Periodic safety update reports for devices: requirements and feedback
The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of the (...)
Combined audits MDD/AIMDD and MDR : requirements and impact on the quality management system
The date after which “legacy devices” can no longer be placed on the market or put into service pursuant Medical (...)
Clinical evaluation: the strategic path of Well Established Technologies (WET) for legacy devices
Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. The (...)
Clinical evaluation: Feedback and good practices
Regulation (EU) 2017/745 (MDR) puts the patient at the center of its scope. This is an important development to strengthen (...)
Article 61(10) of Regulation (EU) 2017/745: Instructions for use and FAQ
According to Article 2(44) of the Medical Devices Regulation (EU) 2017/745 (MDR), clinical evaluation is defined as a “systematic and (...)
In vitro diagnostic software: Novelties introduced by Regulation (EU) 2017/746
Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties introduced (...)
Regulation on medical devices: the news of the month of June decrypted
This special July edition is dedicated to two publications from June and the EPSCO (Employment, Social Policy, Health and Consumer (...)
Summary of Safety and Clinical Performance (SSCP): 5 Challenges to be met
The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III and (...)
UKCA marking: Key steps to consider
The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom Conformity (...)
Transition to European Medical Device Regulation: Feedback and Challenges to be met
Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common denominator (...)
Biological evaluation: chemical characterization according to EN ISO 10993-18:2020
The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the (...)
The Post-Market Clinical Follow-up (PMCF) requirements under the European Medical Device Regulation: Step by Step PMCF
The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. (...)
Introduction to the Regulation (EU) 2017/746
The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)
Clinical evaluation in the era of Regulation (EU) 2017/745
In few months, the European Directives 93/42/EEC concerning medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)
MDSAP Program: Principles, Implementation and Advantages
The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)
Qualification and Classification of Medical Device Software under Regulation (EU) 2017/745
Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient (...)
Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient health. In parallel, development and application of regulatory requirements strengthen controls over medical devices specifically medical device software.