Europe – Commission launches a public consultation and a call for evidence for EU...
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as...
UK – Medical Devices Regulatory Reform – Roadmap to implementation – Update
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition...
Europe – MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of...
The Medical Device Coordination Group (MDCG) has introduced new guidance under MDCG 2024-16, streamlining how manufacturers report interruptions or discontinuations in the supply of...
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...
