In January 2024, a series of new MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance were published on the European Commission website.
These five documents – the first MDCG guidance published this year, consist of a Device Specific Vigilance Guidance (DSVG) Template (MDCG 2024-1) and four further DSVGs for ‘Specific Devices’ including devices for cardiac ablation, coronary stents, cardiac implantable electronic devices and breast implants.
Since this is not an exhaustive list, it is assumed that further DSVGs for said ‘Specific Devices’ will be available in the future.
The purpose of the template and associated examples is to “harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices” and provide clarification for vigilance reporting of such devices to the relevant Competent Authority.
MDCG 2024-1 should be read in conjunction with the requirements of the MDR and IVDR.
These new documents seek to help manufacturers on what to report–specifically incidents, serious incidents, periodic summary reports (PSR) and trends. Examples for certain ‘Specific Devices’ are provided, with applicable clinical references and guidelines also suggested. Notably, these MDCG guidances advise manufacturers to utilize IMDRF codes to categorize the medical device problem (IMDRF Annex A) and associated clinical signs and symptoms (IMDRF Annex A). Manufacturers should consult the most recent version of IMDRF codes provided within each MDCG.
How Can NAMSA Help?
Through experience supporting manufacturers to CE mark approval under the MDR, NAMSA has observed that trending and trend reporting requirements under the MDR are often overlooked and inadequately maintained.
NAMSA’s regulatory consultants can provide practical advice and hands-on support to enable manufacturers to implement and manage trending processes that are robust and applicable to their organization. If you require support with your post-market surveillance, vigilance and trending, Contact Us or learn more about our Regulatory experts here.
David Mandley, PhD
David joined the Regulatory Consulting Team at NAMSA in 2021 and currently serves as a Principal Regulatory Consultant. Mr. Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.