European Commission expert panels on medical devices and in vitro diagnostic devices

Europe – M2M Data Exchange Services Definition (v1 29 May 2019)

M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations...
European Commission expert panels on medical devices and in vitro diagnostic devices

Europe – M2M data exchange services and entity models introduction (v1 29 May 2019)

This document assumes that readers are familiar with the EUDAMED MDR general propose and CEF eDelivery building block (EUSEND) of the Connecting Europe Facility...
European Commission expert panels on medical devices and in vitro diagnostic devices

Europe – EUDAMED UDI Device Data Dictionary

The purpose of this document is to give an understanding over the data that is to be provided to Eudamed and that can be...
Regulatory Recap: Global Trends June 2019

International – Regulatory Recap: Global Trends June 2019

In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified...
Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin

Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs...

Dans la perspective du Conseil européen (article 50) de juin, la Commission européenne a aujourd'hui dressé le bilan – dans sa cinquième communication relative à la...
China’s NMPA reports major decrease in medical device approvals

China – China’s NMPA reports major decrease in medical device approvals

The Chinese National Medical Products Administration (NMPA) has published new data showing a 38% decline in medical device registrations approved by the agency in...
11 Medical Devices Recently Approved by FDA

USA – 11 Medical Devices Recently Approved by FDA

FDA has been busy this year in more ways than one. From warning the public about unauthorized devices,  banning summary reports for breast implants, to drafting...
Lignes directrices de NICE sur les meilleures pratiques avec le PICO[TM]

Europe – Lignes directrices de NICE sur les meilleures pratiques avec le PICO[TM]

La société internationale spécialisée dans les technologies médicales Smith & Nephew (NYSE : SNN ; LSE:SN) approuve l'introduction de la nouvelle directive en matière...
European Commission expert panels on medical devices and in vitro diagnostic devices

Europe – Nouvelle Version 1.22 du Manuel Produits Frontière est sortie

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device,...
The Best Predicate or the Worst?

USA – The Best Predicate or the Worst?

FDA’s 510(k) process requires the comparison of a candidate device to a similar device that is already legally marketable. The objective of this comparison...

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