A legacy medical device is a medical device that was legally marketed prior to the implementation of current medical device regulations or standards, such as the Medical Device Amendments of 1976 in the United States or the Medical Device Directive (MDD) and In Vitro Diagnostic Medical Device Directive (IVDD) in Europe. These devices are often considered outdated in terms of technology, design, or manufacturing practices, and may not meet current regulatory requirements or industry standards.
In both the United States and Europe, legacy devices are subject to certain provisions under the regulatory frameworks. For example, the US FDA may require additional evidence of safety and efficacy for legacy devices to continue to be marketed and used in the future. Similarly, the MDR and IVDR in Europe provide for the continued validity of certificates issued for legacy devices, but legacy devices that do not comply with the regulations may be subject to certain restrictions or even be removed from the market.
Despite their potential limitations, legacy medical devices may still be in use due to their continued efficacy, availability, or the lack of alternative options. However, regulatory bodies may require additional evidence of safety and efficacy for legacy devices to continue to be marketed and used in the future.