Author name: EuMe-adm

Yesterday, revision 1 of the MDCG guidance 2022-9 was published. It provides clarification regarding Summary of Safety and Performance template, especially when devices are intended to be used by lay persons only. Please make sure, that you clearly distinct the user groups in your intended purpose definition and also keep in mind: The Summary of […]

BVMed news: On 11th April 2024, the Bundestag will discuss the impact of the EU Medical Devices Regulation (MDR) on medical device supply. This follows a motion by the Union faction, postponed from January, which calls for: – Complementing the current regulatory system – Increasing the efficiency of the system – Reform of the five-year

Designation of EU Reference Laboratories: The regulation, dated December 6, 2023, designates specific laboratories in the European Union as EU reference laboratories for in vitro diagnostic medical devices. This designation is in accordance with Regulation (EU) 2017/746 and involves a thorough selection process based on criteria outlined in the regulation. Annual Review Process: The Commission

Annual Revision Process: The European Medical Device Nomenclature (EMDN) undergoes an annual review and update process, involving four distinct phases: Collection of requests, Evaluation and analysis, Validation and endorsement, and MDCG endorsement and publication. Actors Involved: The key actors in managing and maintaining the EMDN include the Nomenclature working group (NOM WG), European Medical Device

FDA Update The Food and Drug Administration (FDA) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. The new regulation will incoporating reference to ISO 13485 medical device management system standard (edition 2016) and allows manufacturers to

The EU Commission and Member States have created country language tables in order to provide an overview which language requirements are required by each Member State for following items: – Labelling & Instruction for Use (patient, lay user or professional user) – Implant card – Declaration of conformity – Field safety notice – Graphical user

The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. Class D –> new transition period until December 2027 Class C –> new transition period until December 2028 Class B/A* –> new transition period until December 2029 The proposal will now be forwarded to

Latest MDCG publication regarding vigilance system and device specific vigilance guidance (DSVG) template for different products. MDCG 2024-1 Device Specific Vigilance Guidance Template MDCG 2024-1-1 Cardiac ablation template MDCG 2024-1-2 Coronary stents template MDCG 2024 1-3 Cardiac implantable electronic devices (CIEDs) template MDCG 2024-1-4 Breast implants template Reach out to EUMEDIQ when you need support

EUDAMED was updated (version 2.13. to version 2.14). At a glance it can be said that the update increases usability performance for Competent Authorities and Notified Bodies, especially regarding certificate mangement, SS(C)Ps and their related Basic UDI-DIs. Check out the detailed release notes here.