Member states may either permit or prohibit the reuse or recycling of single-use products at the national level. Under the new MDR, such a “recycler” is considered a manufacturer and must therefore comply with both the regulation requirements and applicable national mandates. The EU Commission has yet to define common specifications on this topic.
In the future, manufacturers of Class I reusable surgical instruments will also need to involve a Notified Body. This Notified Body however will only review the aspects related to the reuse of the products.