France – Diabète: lancement de FreeStyle Libre 3, plus petit et connecté automatiquement au...

PARIS (TICpharma) - Abbott a présenté, le 18 mars lors d'une conférence de presse, son nouveau système de lecture en continu de la glycémie...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – IVDR Watch: European regulators update SSCP rules, high-priority implementation actions and technical...

Medical device manufacturers doing business in Europe should take note of a number of updates affecting in-vitro diagnostic (IVD) medical device regulations set to...

Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète

Le paysage réglementaire mondial continue d'évoluer rapidement en matière de medtech ; de nouvelles exigences sont mises en place et le nombre de marchés...

France – Ethypharm lance la première thérapie numérique dans la dépression sans attendre son...

SAINT-CLOUD (Hauts-de-Seine) (TICpharma) - Ethypharm Digital Therapy (EDT) a lancé le 31 mai en France la première thérapie numérique Deprexis pour la prise en...
New guidance on biologics affects authorized generics

USA – FDA: Nearly 700 breakthrough medical device designations since 2015

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – Notified bodies’ paper on the application of hybrid audits to quality management...

Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023

The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Borderline products: how to tell if your product is a medical device...

Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...

Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of...

Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient...

USA – New rule directs mammography facilities to tell patients about breast density

The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...

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