When would a notified body be involved in relation to in-house devices under MDR 2017/745 or IVDR 2017/746?

Under MDR 2017/745 and IVDR 2017/746, in-house devices are medical devices manufactured and used within a single healthcare institution. Article 5(5) of MDR 2017/745 and IVDR 2017/746 list the conditions to placing these products on the market. A notified body would not be involved in the conformity assessment.

However, these devices are required to be manufactured and used under an appropriate quality management system. Although not a requirement, a manufacturer could choose to undergo certification of ISO 13485 which would involve a notified body review.