Casus Consulting

The EU Commission published a draft amendment to Implementing Regulation (EU) 2021/2226. It proposes expanding the eIFU allowance to all professional use medical devices under the MDR. Below we provide an overview of the changes, and link to the open consultation. https://lnkd.in/g3xe_dmd

The EMDN Working Group published: 1) Minutes from their November 2024 meeting, including timing for the EMDN Help Desk, noted issues around the use of EMDN code “99”, and an update on MeDevIS, the database hosted by the WHO which includes both GMDN and EMDN codes. 2) The presentations from their November 2024 training. Click below to view a recap of both and see what changes are in the pipeline. https://lnkd.in/evpwBAFb

MDCG 2019-6 revision 5 was recently updated. It provides new and expanded definitions, such as consultancy vs regulatory guidance, personnel independence (e.g., the “cooling-off” period for NB personnel who previously worked for a manufacturer), and what is considered “leveraging evidence” to avoid duplication of work. Further, one of the key changes is to add context on "structured dialogues". Read our article for more information on structured dialogues, including how they can help provide manufacturers with more clarity during the CE marking process. https://lnkd.in/gAQq_DeW

Collection of January 2025 updates not already reported on individually, including: newly issued IMDRF guidance on medical device software, revised MDCG documents, update on harmonized standards for the AI Act, and more. #imdrf #mdcg #mdr #ivdr #medicaldevices https://lnkd.in/gvcnfeMq

MDCG documents on EMDN have been newly published: MDCG 2025-1 (ad hoc EMDN request form), MDCG 2025-2 (outcome of 2024 EMDN requests); MDCG 2025-3 (consolidated list of all EMDN code revisions); MDCG 2024-2 rev.1 (Procedure for updates to EMDN) and MDCG 2021-12 rev.1 (FAQs on EMDN). Find out what has changed and how it impacts you. https://lnkd.in/gM_v9zBY

The UK PMS regulation was published in December 2024 and takes effect in June 2025. These PMS requirements impact all devices placed on the Great Britain market, including those that are CE Marked. The MHRA has published new guidance on the PMS requirements, such as the minimum requirements of the PMS Plan, the definition of device lifetime, and more. Click below for the link. https://lnkd.in/gikfj7ZN

MDR/IVDR Article 10a ‘Obligations in case of interruption or discontinuation of supply of certain devices’ is effective 10 January 2025. Find below a free procedure template for manufacturers, available for download in Word format. Plus, information on Article 10a's applicability in Switzerland and the UK. https://lnkd.in/gmr5Edwt

Updates from the MDCG PMS and Vigilance Working Group, including status of the MIR, FSCA, and Trend Reporting Forms & Guidance documents. Plus, MDCG 2023-3 was republished yesterday with some minor revisions. https://lnkd.in/gqjPWbBA

The Commission opened new ‘Have your say’ initiatives for the MDR, such as the proposal to reclassify certain well-established technologies, and to expand the allowance for eIFUs for all professional use devices.?Below we outline the five proposals. https://lnkd.in/ge9-rUxV

Collection of December updates, including newly revised MDCG docs, Team NB’s guidance on expectations at each stage of the MDR Certification process, update on the MHRA's AI Airlock Pilot Program, and more. https://lnkd.in/gEbt85-z