Health institution

Whether an organization is a health institution decides whether it can use the in-house exemption in Article 5(5) of the MDR and IVDR. The term also describes some of the parties a manufacturer must inform under Article 10a.

‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

EU MDR, Article 2(36)

‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

IVDR, Article 2(29)