Europe – MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on...
Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
USA – Industry asks FDA to clarify voluntary malfunction reporting program requirements
Medical device industry groups are asking the US Food and Drug Administration (FDA) to provide more clarity on what products will qualify for its...
Europe – EMA to launch scientific advice pilot for high-risk devices in late February
The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...
USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...
Switzerland – Dealing with certification gaps (MDCG 2022-18)
Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...
USA – FDA final rule reduces radiological devices reporting requirements
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....
USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot
Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA)...
