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Cybersecurity of medical devices

Apr 10, 2017 by BSI
This paper considers the cybersecurity challenges facing the healthcare sector arising from the convergence of technology, hyper-connectivity and recent developments in regulation. It explains the issues and tensions between safety and security and what can be done to resolve them. The paper highlights emerging good practice and approaches that manufacturers can take to improve medical device security throughout its lifecycle. The paper will also be of interest to others in the sector, including healthcare providers, IT suppliers, notified bodies and regulators.  Download whitepaper (...

Infraction à la loi anti-cadeaux : amende record de 75 000€ pour le mandataire social

Apr 10, 2017 by Olivier Lantrès, avocat associé, et Sébastien Pradeau, avocat au cabinet Fieldfisher
La Cour d'appel de Paris a rendu la semaine passée, un arrêt très sévère à l'encontre d'une entreprise commercialisant des produits de santé, dans le domaine dentaire. L'arrêt est transposable à tout type de producteur et distributeur de produits de santé, directement ou indirectement remboursés, ainsi qu'aux prestataires de santé... Lire la suite sur slideshare

Medical devices: Virtual Manufacturing replaces Own Brand Labelling

Mar 30, 2017 by MHRA
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product. MHRA is replacing the term ‘own brand labelling’ with ‘virtual manufacturing’. All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name. Medical devices: Virtual Manufacturing replaces Own Brand Labelling

Common issues identified during clinical trial applications

Mar 23, 2017 by MHRA
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them. The Medicines and Healthcare products Regulatory Agency (MHRA) receives more than 1000 clinical trial authorisation (CTA) applications for investigational medicinal products (IMPs) per year. The great majority (up to 95%) of these are approved; however, more than half of all applications require additional information to be submitted before they are considered approvable. Many of the requests for further information or ‘grounds for non-acceptance’ (GNA),...

Medicines: get scientific advice from MHRA

Mar 16, 2017
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees. Overview You can ask for scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) at any stage of the initial development of your medicine, before you have submitted your application for a marketing authorisation (MA) (product licence) and during the pre-submission period for a variation to an existing MA. Meetings can also be held with the MHRA to discuss: pharmacovigilance advertising proposals to...

Leadless cardiac pacemaker therapy:new guidance from an MHRA Expert Advisory Group

Mar 14, 2017
Initial recommendations from on leadless cardiac pacemaker therapy from MHRA Expert Advisory Group. In 2015 the MHRA’s Devices Expert Advisory Committee (DEAC) commissioned the Expert Advisory Group on leadless cardiac pacemaker devices. The group was tasked with producing a framework document aimed at manufacturers and notified bodies to cover best practice in: pre-market clinical evaluation of current and planned devices, including advice on pre-market clinical trial design post-market clinical evaluation of current and planned devices and evaluation of...
Medical Device

Development and validation of programmable electro-medical systems

Mar 13, 2017 by Robert Benzaki, Ing. SupElec
According to directive CEE 93/42 as amended, a medical device could be a software either embedded or stand-alone as well as a programmable electro-medical system. As for all devices, a programmable electro-medical system must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed...

Poster: How are ophthalmic medical devices regulated in Australia?

Mar 10, 2017 by Mario Vittorino
Association for Research in Vision and Ophthalmology Asia Conference, 8 February 2017 Poster by: Mario Vittorino, Devices Clinical Section, Medical Devices Branch, Therapeutic Goods Administration Presented at: Association for Research in Vision and Ophthalmology Asia Conference Presentation date: 8 February 2017 Poster summary: The Therapeutic Goods Administration requires manufacturers of high-risk ophthalmic devices to demonstrate safety and effectiveness before the devices can be marketed. This poster presentation describes a study of the TGA's evaluation process...

Procédure de demande d’inscription d’un produit ou d’une prestation

Mar 6, 2017
Notice d’information relative à la procédure de demande d’inscription d’un produit ou d’une prestation sur la liste mentionnée à l’article L.162-22-7 et aux critères d’inscription, de non inscription et de radiation d’un produit ou d’une prestation sur la liste mentionnée à l’article L.162-22-7 du code de la sécurité sociale. Contexte Le financement des dispositifs médicaux au sein des établissements de santé est assuré par les tarifs des prestations définis à l’article L.162-22-6 du code de la sécurité sociale. Par dérogation, et afin de soutenir et diffuser l’innovation dans les...

Jugements de l’affaire TÜV/PIP : jusqu’où va la responsabilité des organismes notifiés ?

Feb 20, 2017 by Anne-Catherine Perroy, Of Counsel, Simmons & Simmons LLP & Emmanuel Garnier, Avocat Senior, Simmons & Simmons LLP
Par deux jugements du 20 janvier 2017, le Tribunal de commerce de Toulon a condamné solidairement les sociétés TÜV Rheinland France et TÜV Rheinland LGA Products GmbH à payer à chacune des demanderesses une provision d’un montant de 3.000 euros en réparation des préjudices matériels et immatériels causés aux distributeurs des produits de la société PIP d’une part, et les préjudices corporels et/ou psychologiques causés aux porteuses d’implants mammaires de marque PIP d’autre part (« Jugements »). Aux termes des Jugements, qui marquent un nouvel épisode dans le cadre des...



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