Trois nouvelles guidances du MDCG en Mars 2020

Europe – Proposition de la Commission Européenne au Parlement pour reporter d’un an la...

Le règlement (UE) 2017/745 du Parlement européen et du Conseil, adopté le 5 avril 2017, établit un nouveau cadre réglementaire visant à garantir le bon...

Europe – Launch of TEAM-PRRC : Persons Responsible for Regulatory Compliance

TEAM-PRRC is a not-for-profit European association of “Persons Responsible for Regulatory Compliance - PRRC” as per Article 15 of EU Medical Device Regulations (EU)...
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...

USA – BARDA opens research portal to combat COVID-19 pandemic

The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness...

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...

France – Le pôle Medicen recense les initiatives contre le Covid-19

Face à l’épidémie de Covid-19, le pôle de compétitivité Medicen Paris Region publie une "boîte à outils" afin de donner aux acteurs publics et...

USA – What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of...

As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per...

France – Coronavirus : Thuasne se lance dans la production de masques barrières réutilisables

En pleine épidémie du coronavirus, Thuasne apporte sa contribution à la fabrication de moyens de protection pour la population saine. Spécialisé dans la fabrication de dispositifs...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including...
New guidance on biologics affects authorized generics

USA – Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease...

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious...