USA – Final FDA guidance on PCCP includes clarification on version control
The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices...
Europe – MDCG 2024-15 – Guidance on the publication of the clinical investigation reports...
Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within...
Europe – Medical devices AI questionnaire IG-NB & Team NB
This questionnaire is jointly published by the German Notified Bodies Alliance for Medical Devices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IGNB)...
Europe – MDCG 2024-14 – Guidance on the implementation of the Master UDI-DI solution...
The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR) aims to...
France – PLFSS 2025: le gouvernement veut actionner la clause de sauvegarde sur les...
Le gouvernement a déposé un amendement (au PLFSS 2025 afin- de modifier le montant Z au-delà duquel la clause de sauvegarde "produits et prestations"...
Europe – Gradual roll out of EUDAMED – Q&As on practical aspects related to...
The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics:
1. Regulation (EU) 2024/1860 aims to ensure a high...
USA – FDA finalizes guidance on 510(k) third-party reviews
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance to assist manufacturers in using an...
USA – The regulatory landscape of ingestible medical devices in the United States
Ingestible medical devices offer novel diagnostic, monitoring, and treatment capabilities. This article explores the regulatory landscape of ingestible devices in the US, highlighting the...
UK – Medical Devices Regulations: Routes to market and in vitro diagnostic devices
This consultation applies to medical devices in Great Britain. For guidance on the
regulation of devices in Northern Ireland, see Regulation of devices in Northern...
France – Implants et prothèses dentaires : avis favorable de la HAS pour leur...
Alors que le nombre de personnes concernées par la perte d’une voire de l’ensemble des dents est amené à croître, la pose d’implants n’est...
