Newsletters

The Post-Market Surveillance (PMS) system is an essential process for ensuring the safety and effectiveness of medical devices placed on (...)

The Medical Device Single Audit Program (MDSAP) initiative started in 2012 and has been fully operational in 2017. Since then, (...)

Since the early 2000s, particularly in Europe, there has been a growing awareness of the impact of chemical substances on (...)

The involvement of European Union Reference Laboratories (EURLs) is a new requirement described in Article 100 of Regulation (EU) 2017/746 (...)

On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on (...)

Regulations (EU) 2017/745 & 2017/746 introduce “new” requirements for distributors and importers who carry out activities involving the repackaging, supply (...)

The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of the (...)

The date after which “legacy devices” can no longer be placed on the market or put into service pursuant Medical (...)

Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. The (...)

Regulation (EU) 2017/745 (MDR) puts the patient at the center of its scope. This is an important development to strengthen (...)

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 (...)

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