The European Commission (EC) on Tuesday set forth the common specifications (CS) for the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR).
The EC is proposing the CS via a draft implementing regulation to specify requirements for the reprocessing of single-use medical devices in alignment with criteria in Article 17(3) of MDR.
EU member states may choose not to apply rules relevant to manufacturers’ obligations for single-use devices reprocessed and reused within health institutions provided that the safety and performance profile of the reprocessed device is equivalent to that of the original device and that the reprocessing is performed in accordance with the CS. MDR also allows member states to elect to apply such rules for an external reprocessor to reprocess single-use devices at the request of a health institution subject to both of these criteria from Article 17(3). The new implementing regulation will instruct on how to meet the criteria through compliance with the CS.
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