The European Commission is considering allowing, in general but not in all cases, the reprocessing of medical devices intended for single use, as long as specific criteria are met.

But equally, it is also in favour of allowing member states to maintain or introduce national provisions that either prohibit just the reprocessing of single-use devices, or prohibit reprocessing these devices and making them available. The discrepancy here is presumably that the device might have been reprocessed in one country, but then sold in another.

Where member states decide to introduce their own national provisions, they would be expected to notify the commission and other member states, providing details of their grounds for opting out.

The commission would then keep member state decisions publicly available, information obtained by Clinica suggests.

Reprocessing of devices for critical use to be banned

The commission also wants to ban the reprocessing of “single-use devices for critical use”. These products are intended to be used for surgically invasive medical procedures and which need to be sterilised prior to their use.

Here, some exceptions may apply. The commission is looking to keep an up-to-date list of categories or groups of single-use devices for critical use which may be reprocessed where specific recommendation has been made by the Scientific Committee for Emerging or Newly Identified Health Risks (SCENIHR).

Reprocessing comes with big responsibilities

Under the scheme being considered by the commission, the company reprocessing single-use devices would be considered the manufacturer of the products, and have to meet the same responsibilities as the devices' original manufacturers, as laid out in the EU medtech regulations. The details of these device reprocessors would have to appear on the product's label and instructions for use, in place of those of the original manufacturer.