Main Article Content
Abstract
Implantable medical devices represent a critical advancement in modern healthcare, offering therapeutic solutions for a wide range of clinical conditions. As these devices are designed for prolonged or permanent interaction with internal tissues, ensuring their safety and biocompatibility is paramount. This review provides an overview of current regulatory definitions and classifications of implantable devices, with a particular focus on frameworks established by the European Union and other international regulatory bodies. It further explores the concept of biocompatibility, including material considerations, selection criteria and the diverse range of natural and synthetic biomaterials used in device fabrication. A detailed examination of standardized biocompatibility testing methods is presented, based on the ISO 10993 series and related guidelines, encompassing cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, genotoxicity, and more. The review emphasizes the importance of both preclinical and post-market evaluations in ensuring long-term device performance and patient safety. Advances in biomaterials and testing technologies are also discussed, highlighting the shift towards risk-based assessments and reduction in animal testing. Overall, the review underscores the need for rigorous, context-specific evaluations to support the safe and effective integration of implantable medical devices into clinical practice.