Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
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...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
France – HAS: Vers un cadre commun d’évaluation des dispositifs médicaux numériques en Union...
Un des objectifs de la Présidence française du Conseil de l’Union européenne (PFUE) était de faciliter la mise en place d'un « marché unique...
USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do...
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The...
USA – FDA proposes updates to Breakthrough Devices Program guidance
The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its...
France – Intelligence Artificielle et DM : le brouillard des règles à appliquer
Depuis plusieurs années, l’intelligence artificielle se répand rapidement dans les solutions proposées par les fabricants de dispositifs médicaux et de dispositifs de diagnostic in vitro,...
UK – MHRA : Implementation of the Future Regulations
The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to...
UK – Implementation of the future regulation of medical devices and extension of standstill...
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....
USA – FDA issues road map to medical device regulatory guidance topics list for...
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...
