Newsletters

Clear search
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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. (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

Learn more
Newsletters

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 (...)

Learn more
Newsletters

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 (...)

Learn more