Westfield Medical Ltd

Westfield Medical Ltd specialises in surgical devices for hernia repair and tissue integration. Their portfolio includes the AHS (Active Healing System) and BHS (Biodegradable Hernia System), which are designed for use in minimally invasive procedures. These devices provide absorbable or resorbable materials to aid wound healing and structural reinforcement during surgery.

Westfield Medical Ltd is based in the United Kingdom, which places it under EU regulatory jurisdiction. Since their devices fall under EU medical device regulations, they must comply with EU-wide requirements, including registration in the eudamed database. The UK’s alignment with EU medical device standards ensures their products meet the necessary regulatory criteria for market placement.

Westfield Medical Ltd’s devices are listed in the eudamed database, the official EU registry for medical devices. Listing in eudamed is mandatory for Class I devices under EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring transparency and traceability for regulatory authorities, healthcare providers, and patients. It also facilitates compliance verification during market surveillance.

Westfield Medical Ltd’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk devices that pose minimal risk to patients and users, such as the AHS and BHS systems. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, but still must comply with essential safety and performance requirements to ensure their safety and effectiveness.