|Theme||In house devices|
|Target Audience||Health institutions, healthcare professionals|
|Products concerned||MD, IVD|
|Regulatory reference||MDR (EU) 2017/745
IVDR (EU) 2017/746
|Documents mentioned||MDCG 2020-16
This MDCG document addresses so-called “in house” devices, i.e., devices manufactured and used exclusively in health care facilities on a non-industrial scale to meet the specific needs of target patients that cannot be met by an equivalent CE-marked device on the market.
These in-house devices are exempted from many of the requirements of the MDR and IVDR provided that the healthcare institutions in charge of them comply with the conditions set forth in Article 5(5) of these regulations. This guide therefore provides recommendations on the application of these rules and is intended in particular for healthcare professionals who design, modify, or use this type of device in-house.