As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under...

Europe – Euro Convergence: Suboptimal use of MDR grace period is storing up trouble

Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity...
Singapore HSA revises guidance and technical documents

Singapore – HSA will introduce UDI labeling requirements for medical devices

Singapore’s Health Sciences Authority (HSA) has announced that it will introduce a Unique Device Identification (UDI) system to be used for medical devices. The...

France – La HAS guide les demandes d’évaluation de DM embarquant de l’intelligence artificielle

PARIS (TICpharma) - La Haute autorité de santé (HAS) a fait part le 14 octobre dans un communiqué de la mise à jour de...

Europe – SCHEER : Preliminary Opinion on the safety of breast implants in relation...

The SCHEER was requested by the European Commission to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell...

France – Implant files : le Tribunal Administratif contraint le GMED de dévoiler certaines...

C’est une demi-victoire que le tribunal administratif a accordée à la liberté d’expression face au secret des affaires. Dans un jugement rendu le 15 octobre,...

USA – US FDA presents premarket submissions pilot program and patient-centered data resource pages

The US FDA’s Center for Devices and Radiological Health (CDRH) has introduced a new pilot program for a different method of electronic premarket submissions...
IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – IMDRF proposes update on postmarketing device studies

The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – EUDAMED : Actor registration module

The European Commission will make available the Actor registration module to Member States and economic operators from 1 December 2020. It is the first of...
Norway’s DNV GL Designated as 10th Notified Body Under MDRClinical Trials With Conditions

Europe – Are your clinical activities in compliance with European standards for good clinical...

Many medical device manufacturers will be strongly impacted by new requirements for more clinical evidence once the European Medical Devices Regulation (MDR) comes fully...

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