Check-Ups and Help
More often than not, the classification of health-apps as medical products and the assessment as a risk product proves to be a challenge. That the Medical Product Legislation is ever-changing makes it even more difficult.
In particular, the transitional period of the Medical Device Regulation (in short: MDR), which won't expire on May 26th, 2020, should be kept in mind, as it is accompanied by a change of the assessment framework, especially for health apps.
Although providers of health apps can influence the classification of their products through a subjective product description or purpose, this conversely means, that corresponding descriptions and advertising statements need to be coordinated precisely, to comply with limitations.
That's why VORBERG.LAW offers medical product check-ups for health apps, in course of which we check the product presentation and assess whether the app is a medical device at all and - if so- which risk class it presents itself within.