Medical device CE marking

Common Specification for reprocessing of single use devices


The European Commission has published the first common specifications under the MDR. It concerns reprocessing of single use devices.

Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.

To ensure the quality of the reprocessing activities, CS concerning risk management should include minimum requirements for staff, premises and equipment.