Medical devices can be manufactured and used within EU health institutions (in-house
devices), on a non-industrial scale, to address the specific needs of target patient groups
which cannot be met, or cannot be met at the appropriate level of performance, by an
equivalent CE-marked device available on the market. In-house medical devices are
exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices
Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation. In order to ensure the highest level of health protection, Article 5(5) sets a number of rules regarding the manufacture and use of such in-house medical devices…
