Certification of medical apps:

Medical apps are rapidly gaining ground in the world of healthcare. Healthcare professionals are assisted in their jobs by medical apps facilitating a diagnosis or treatment of the patient and consumers are assisted by medical apps facilitating in medical diaries or in deciding whether one should seek the help of a healthcare professional or not. However, most people don’t realize themselves that medical apps are in certain cases considered as medical devices and as such these kind of apps should meet the requirements of Dir. 93/42/EC. In the Netherlands the “Inspectie voor de Gezondheidszorg (IGZ)” has announced on the Mobile Healthcare Congress of 2012 that they will inspect in 2013 whether medical apps are properly certified. Therefore, don’t hesitate to contact us if you doubt whether your medical app should be certified or not.

Does your medical app need certification?

Please send us your contact details and a short description of your medical app. YES Pharma Consultancy B.V. will evaluate whether your medical app needs to be certified conform Dir. 93/42/EC in a very short time period. We will send you an assessment report and an advice concerning the need for certification; the costs are ϵ 400,- per medical app.