MDR state of play – where are we at and where do we need to be?

Stefan Bolleininger (Managing Director be-on-Quality) will be discussing this at DIETZ Consultants’ 2nd Medical Devices Risk Management Forum on December 3 and 4, 2019 in Nuremberg. Current decisions and informational situations within the EU will be getting the most attention. With this guest article in our FMEA blog, he gives us a sneak preview of his talk.

Which boundary conditions does the MDR specify, and where is there still some leeway?

The MDR is still in the transition period. This gives us a great deal of leeway for designing the relevant technical documentation and the crossovers between risk management, clinical data, and technical documents. It is therefore a good idea to see the regulations as boundary conditions and to think about our own goal-setting. The MDCG’s guidance on the qualification and classification of software can be cited as an example here. There are a lot of gray areas here, which the manufacturer has to define for itself.

The key questions that need to be answered are: What boundary conditions does the MDR already impose on us, and where do we still have potential for our own development? And where will we be facing yet more changes in the coming months?

From implementation objectives through to implementation options

Based on the current audit situations, the current status in Brussels and Berlin, and the latest information, the Medical Devices Risk Management Forum talk will propose a package, presenting the relevant implementation objectives and offering options for your own implementation. Spanning the technical documentation and associated topics, the main points from the last changes will be identified and a concise position taken on the basis of this.

To analyze the current situation and derive appropriate measures, one of the tools used will be best practice examples.