Newsletters

According to Article 2(44) of the Medical Devices Regulation (EU) 2017/745 (MDR), clinical evaluation is defined as a “systematic and (...)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties introduced (...)

This special July edition is dedicated to two publications from June and the EPSCO (Employment, Social Policy, Health and Consumer (...)

The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III and (...)

The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom Conformity (...)

Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common denominator (...)

The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the (...)

The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. (...)

The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)

In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)

Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient (...)