Europe – Notified body official shares recommendations for successful PMCF plans
Successful postmarket clinical follow-up plans (PMCFs) should be able to provide new information that was not previously known about a device, such as delayed...
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...
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...
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...
Europe – Experts: Notified body survey shows MDR/IVDR progress despite some snags
A recent survey shows progress in the number of applications being filed with notified bodies (NB) and certificates issued under the EU Medical Device...
Europe – MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical...
Europe – Q&A Obligation to inform in case of interruption or discontinuation of supply
Introduction – Objectives of the MDR/IVDR amendment
The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics:
1. Regulation (EU)...
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...
