Health institutions have the possibility to manufacture, modify and use devices in-house. Thereby, they address the specific needs of target patient groups on a non-industrial scale. This applies especially if these needs cannot be met at the appropriate level by an equivalent device available on the market. With that in mind, certain rules of the Regulation should not apply since its aims would still be met proportionately (Regulation (EU) 2017/745 (MDR) Article 5(5) and Regulation (EU) 2017/746 (IVDR) ) Article 5(5)).
This applies specifically to medical devices manufactured and used strictly in health institutions. Examples include hospitals, but also laboratories and public health institutes that support the healthcare system and/or address patient needs, but do not treat or care for patients directly.
The concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption for health institutions does not apply to such establishments.
