Author name: EuMe-adm

Yesterday, MDCG published draft guidance with useful recommendations for content of Investigator’s Brochure for Clinical Investigations Important note: draft document See full document here: https://www.linkedin.com/feed/update/urn:li:activity:7186772498154168322

See full document here:  https://www.linkedin.com/feed/update/urn:li:activity:7186313929193574400

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

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 profit not