SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

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...

Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations. This...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list

European regulators just updated the harmonized standards list for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) days ahead of its implementation date on May...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body...

The MDCG recognises that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical...

Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR...

In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR), a device may be placed on the market only if it complies...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Le règlement (UE) 2023/607

Le règlement (UE) 2023/607, publié au JOUE, modifie les dispositions transitoires relatives à certains dispositifs médicaux et à certains dispositifs médicaux de diagnostic in...

UK – NICE recommends flash devices to type 1 diabetes patients

Over 250,000 people living with type 1 diabetes are set to be offered new technology to help them manage their condition, following the latest...
Vers une plus grande coopération des pharmacopées mondiales

Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?

Le règlement européen (UE) 2017/745 (RDM) est applicable depuis le 26 mai 2021, et tous les fabricants qui mettent sur le marché des dispositifs...

Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical...

‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify...

Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...

La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...

NOS PROCHAINES FORMATIONS