On July 23, 2019, the European Commission published the draft of the “Commission Implementing Regulation […] as regards common specifications for the reprocessing of single-use Medical Devices”. The document was released ahead of time, with expected date of final adoption set on November 2019, according to the latest EC’s MDR/IVDR Rolling Plan of essential implementing acts and actions, and is currently under public consultation until August 20, 2019.
Pursuant to Art. 17(5) of Regulations MDR (EU) 2017/745, the reprocessing of single-use devices is allowed, provided it is performed in accordance with Common Specifications (CS) meant to ensure the safety and performance of the reprocessed single-use devices. The draft Regulations thus outline the requirements for the reprocessing of single-use devices, among them:
- risk management, including the analysis of the construction and material, the preliminary assessment of the suitability of a single-use device for reprocessing, the monitoring of changes made by the manufacturer of the original device and the maximum number of reprocessing cycles;
- the validation of procedures for the entire process of reprocessing, including cleaning steps, the monitoring of sterilization cycles;
- the quality management system, including an annual audit, the collection of information regarding serious incidents arising in connection with reprocessed device, as well as the reporting of incidents involving devices that have been reprocessed;
- the traceability of the reprocessed single-use devices: tracking of reprocessing cycles and maintaining records of all the reprocessing process steps.
Once adopted, the Regulation shall enter into force after 20 days following its publication in the EU’s Official Journal and shall apply from May 26, 2020.