France – DTx : la réglementation se met progressivement en place

Les DTx (pour Digital Therapeutics) sont des dispositifs médicaux (DM) d’un nouveau genre qui entendent alléger, compléter voire remplacer la prise de médicaments. Leur...

Europe – Overview of language requirements for manufacturers of medical devices

The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical devices: UK approved bodies

Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Implementation of medical devices future regime

On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The...
Modalités de dépôt d'un dossier de demande d'évaluation d'acte professionnel

France – Diagnostic complexe d’endométriose : la HAS propose un accès au test salivaire...

En France, près de 2 millions de femmes adultes sont susceptibles de se demander si une endométriose est à l’origine de leurs douleurs pelviennes...

USA – FDA updates sterilization category to encourage vaporized hydrogen peroxide use

The US Food and Drug Administration (FDA) has recategorized vaporized hydrogen peroxide (VHP) as a sterilization agent, signaling to medical device manufacturers that it...

Canada – Amendments to the Medical Devices Regulations to address future public health emergencies

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations...

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if: — the device has been designed by modifications of...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – New organisational structure with separate Medical Devices Surveillance Sector

For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....

UK – Heart vests to identify those at high risk of sudden cardiac death

In the UK, heart rhythms affect around two million people and can cause sudden death. A re-useable heart vest developed by researchers from University College...

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