Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation

Abstract

Abstract In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clinical findings create permanent needs to match the standardization. Therefore, a set of international standards is analyzed with respect to their use for particular coronary drug-eluting stents and artificial heart valves. It was found that standards (ISO, ASTM) exist for general requirements on passive implants, but also specifically relate to arterial stents, stent grafts, bioresorbable and drug-eluting stents, as well as artificial heart valves. New work items address new methods for characterization of coating integrity, particulate matter and simulated use testing. European Medical Device Regulation (MDR) requires technical expertise and capacity at Notified Bodies supported by independent test laboratories. Generally, the interest in standardization from industry, test laboratories and authorities is high, but more input from medical experts would further improve the value of standardization and its relevance for safe and even more effective implants.