Europe – Commission proposes measures to improve the availability of in vitro diagnostics
Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this...
Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and...
The Communication of the Commission of 11 December 2019 on ‘The European Green Deal’ (the ‘European Green Deal’) is Europe’s growth strategy that aims...
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...
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...
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...
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...
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...
