MDCG guidance on application of MDR Article 5(5) to in-house medical devices published
3 March 2023
The guidance “MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746“, co-developed and endorsed by the Medical Device Coordination Group (MDCG), was published on January 10, 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 in-house devices. The MDCG guidance 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, the MDCG guidance document intends to foster harmonised application of Article 5(5) by the national competent authorities.
Regulation (EU) 2022/112 deferred the application of some, but not all, provisions for in-house IVDs. A schematic overview of the timing of the applicability of IVDR Article 5(5) provisions can be found in Annex B of the MDCG guidance. It should be noted that the corresponding Article 5(5) of the MDR has already been fully applicable since 26 May 2021.