Publication date 10 January 2023
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.
The provisions in Article 5(5) are the basis for the regulatory control and oversight of inhouse devices. This document provides guidance on the application of some of these rules.
It is written for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use in-house devices. In addition, this guidance document intends to foster harmonised application of Article 5(5) by the national competent authorities.
Both Regulations also state that any natural or legal person offering diagnostic or therapeutic services through distance sales to patients in the Union must use devices that comply with the MDR or IVDR (Article 6(2)). Of importance here is that the exemption provision from Article 5(5) is only applicable to health institutions within the Union.
While most recommendations in this document pertain to both medical devices and in vitro diagnostic medical devices (IVDs), some are specific to IVDs; such cases are explicitly mentioned.
Regulation (EU) 2022/112 deferred the application of some, but not all, provisions for inhouse IVDs. A schematic overview of the timing of the applicability of IVDR Article 5(5) provisions can be found in Annex B of this guidance. Note that the corresponding Article 5(5) of the MDR has already been fully applicable since 26 May 2021.