Single-use devices under MDR receives specification offers for reprocessing from European Commission


The single-use medical devices under the Medical Device Regulation (MDR) of the European Commission (EC), receives Common Specifications (CS) for reprocessing. The Common Specification (CS) is drafted following the criteria in Article 17(3) of the MDR.

The specifications depicted that the rules complying to manufacturer's obligation towards the single-used device, may not be chosen to be applied by the EU member state, to be reprocessed and reused within health institutions. The specifications can be applied if the reused and reprocessed single-use devices are equivalent to the original devices