The European Medicines Agency (EMA) has accepted a group of variations to the marketing authorisation for the Surgiflo Haemostatic Matrix Kit, a medical device used to control bleeding during surgery, including the addition of an alternative pre-filled syringe containing sterile water for injection. The changes, detailed in a document published on 7 August 2026, cover minor and major modifications to the ancillary medicinal substance used with the device, and were accepted following a post-consultation procedure.
The document, titled "Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation," outlines two groups of variations. The first, a type IB variation with outcome dated 3 August 2026, involves submitting a 2nd step notification procedure. The second, a type II variation with outcome dated 9 October 2025, encompasses six specific changes: replacing non-significant parameters in the specifications of the finished product water for injection; adding an alternative pre-filled syringe containing sterile water for injection to the medical device; changing the immediate packaging of the sterile finished product pre-filled syringe; adding an alternative site responsible for manufacturing the finished product; adding an alternative site for quality control testing and batch release; and submitting 2nd step notification procedures for the pharmaceutical manufacturing facility (PMF).
The variations were classified as minor changes equivalent to IA or IB, and major changes equivalent to II, all accepted by the agency. The product information affected includes the summary of product characteristics, labelling, and package leaflet, though the specific sections impacted are not detailed in the document.
These procedural steps follow the initial consultation for the Surgiflo Haemostatic Matrix Kit, which is manufactured by Ferrosan. The kit combines a haemostatic matrix with a pre-filled syringe of sterile water, used to facilitate mixing before application. The acceptance of these variations ensures the continued availability and compliance of the product within the EU market.
The document is part of EMA's regulatory oversight of medical devices that incorporate ancillary medicinal substances, a category that requires assessment under both medical device and pharmaceutical regulations. The agency's decision reflects its role in ensuring that any changes to such products meet safety and quality standards.
For healthcare providers and patients, the addition of an alternative pre-filled syringe and the changes to manufacturing sites are unlikely to alter the clinical use or performance of the device, but they may affect supply chain logistics. The manufacturer, Ferrosan, will need to implement the changes in accordance with the accepted variations, ensuring that all new sites and specifications comply with good manufacturing practices.
The EMA's publication of these procedural steps provides transparency on the regulatory status of the product, which is important for distributors and healthcare institutions that rely on the device. No further regulatory action is indicated at this stage, as the variations have been accepted.