The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
Reprocessing refers to the method through which you can reuse medical devices safely and effectively. The European Union Medical Device Regulation (EU MDR) 2017/745 describes the word “reprocessing” as exclusively used for single-use devices, while it describes the reprocessing of reusable devices as “the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilization appropriate to the member state or the member states in which the device has been placed on the market. “
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
