France – Sécurité: la base de données médicales Claude Bernard décroche la certification ISO...

La base de données sur les médicaments (BdM) Claude Bernard, filiale du groupe Cegedim, a obtenu la certification ISO 13485 qui renforce les exigences...

Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems

On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive.  The draft Directive is intended to complement the...
India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India – Indian regulators add to list of medical device testing laboratories

Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...

Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private...

The Australian Therapeutic Goods Administration (TGA) updated several regulations, including medical devices and in vitro diagnostic (IVD) devices under Australian legislation. Changes involve clinical...

USA – We keep trying to make AI therapists. It’s not working.

We keep failing at making an artificial-intelligence Sigmund Freud, and there is both value and risk in leaning on technology to improve our mental...

Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’

This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...

Europe – MedTech Europe’s vision for a resilient medical technology ecosystem

The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...

Europe – New European Manual on Borderline and Classification for medical devices and IVDs...

Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of...

UK – New device launched for diagnosing prostate cancer

CamPROBE may save vital time and money while reducing the risk of infection November will witness the launch of a new device that is set...
ANSM – Comité d’interface du 6 Février – EUDAMED

France – Cybersécurité des DM et DMDIV

Ce document est un recueil de recommandations à l’attention des fabricants de DM et DMDIV. L’objectif est de les guider pour prendre les mesures...

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