Repeated cleaning, disinfection and sterilization validation related regulations:
MDR Article 52
l Conformity assessment: The self-declared notified body intervenes in the aspects related to the reuse of the product, including cleaning, disinfection, sterilization, maintenance, functional testing and related instructions for use
MDR Annex I Chapter 3. 2.3.4
l Provide information on the reprocessing process, including cleaning, disinfection, packaging and, where appropriate, confirmed methods of resterilization for the Member State in which the device is placed on the market;
l Provides information to identify when the device should no longer be used. If the service life of the product depends on the number of repeated uses, a method should be provided to identify the number of repeated uses of the device;
l The reprocessing methods provided shall be confirmed and shall take into account their applicability in the Member State in which they are placed on the market.
Scope of application:
Medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.
SERVICE PROCESS,PRICE & DELIVER
