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

Europe – EU Regulatory Roundup

MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted...

Europe – Contaminants inorganiques : les atouts des méthodes d’analyse spécifiques (Ref. norme ISO...

La norme ISO 19227 posant les principes de qualification du nettoyage pour les implants orthopédiques est désormais bien établie, y compris pour les dispositifs...

Europe – Evaluation biologique des dispositifs médicaux : de la méthodologie à la pratique

En cette période de confinement forcé, et de télétravail, nous avons souhaité vous offrir ce dossier qui, à notre sens est unique. Rédigé par...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Normes Européennes Harmonisées : Mise à jour Mars 2020

LA COMMISSION EUROPÉENNE, vu le traité sur le fonctionnement de l’Union européenne, vu le règlement (UE) no 1025/2012 du Parlement européen et du Conseil du 25...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK announces COVID-19 regulatory response measures

The United Kingdom has experienced several regulatory updates, as the Medicines and Healthcare products Regulatory Agency (MHRA) releases new documents and announces changes to...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Coronavirus: harmonised standards for medical devices to respond to urgent needs

Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health...
Trois nouvelles guidances du MDCG en Mars 2020

Europe – The European MDR and human factors engineering: Intended purpose

In the second blog post in our series on human factors engineering and the European Medical Devices Regulation (MDR), we will discuss intended purpose: how...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – EU guidance documents offer additional details on MDR transition

The European Union’s Medical Device Coordination Group (MDCG) published three new guidance documents and revised existing ones. Much of this new material addresses issues...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – Implementation of the MDR most likely postponed by one year

Directly related to MDR implementation the Commission has carefully evaluated the impact of COVID-19 on the implementation of the MDR . The COVID-19 situation...
EU Advances SPC Waiver Proposal

Europe – Vers un report du RDM d’un an ?

Il fallait s’y attendre. L’épidémie de COVID-19 est un beau et vrai prétexte à saisir par la Commission Européenne pour palier les carences en...