Digital health products and MDR

-Classification, reclassification and some practical regulatory and other legal consequences

Digital health and care have the potential to innovate and improve access to care, quality of care, and to increase the overall efficiency of the health sector. In this breakfast seminar we will look at some key regulatory and other legal issues relevant for existing and new digital health products intended for the EU market.

The European Medical Device Regulation (EU/2017/745, the MDR) will give reason to take a new approach to the classification of software and other digital products under the EU medical regulatory regime. For example, under the MDR software intended to provide information which is “used to take decisions with diagnosis or therapeutic purposes” will fall into class IIa or higher under rule 11 of the MDR, which will broaden the area for class II certification considerably.

In this seminar we will go through the basic principles of classification of software medical devices under rule 11 of the MDR, the practical application of that rule and the re-classification that may follow. We will put focus on the key areas that would need to be addressed as a result of a reclassification and on how to structure the implementation of such changes, in particular with respect to software that under the current regime is class I devices and under the MDR will fall into class II or higher.

All manufacturers will under the MDR be required to analyse and verify (or amend) certain aspects of its relationships in the supply chain and distribution channels. In this seminar we will identify the key issues to be addressed and provide practical examples of how to implement them in new or existing agreements.