T 0663/02 du 17.03.2011

I. The fact that an intravenous injection of a magnetic resonance contrast agent can be delegated by a physician to a qualified paramedical professional indicates that such an injection may be considered as representing a minor routine intervention which does not imply a substantial health risk when carried out with the required care and skill. Such acts would be ruled out from the scope of the application of the exclusion clause pursuant to Article 53(c) EPC following the narrow understanding advocated by the EBA (G 0001/04 and 0001/07) (Reasons, 3.2.4).

II. A possible way of assessing health risks is to use a risk matrix permitting to combine the levels of likelihood and health impact of a complication of a medical act with regard to a large number of patients, so as to obtain statistical health risk scores which may be used to decide what action should be taken. Such a risk assessment supports the view that an intravenous injection of a magnetic resonance contrast agent represents a minor routine intervention involving no substantial health risks when carried out with the required care and skill (Reasons, 3.2.5).