Future State of Europe

Seven years after coming into force of EU MDR, we can conclude that its implementation has been a cumbersome process, to say the least. Years of extension have been granted to fix the claimed notified body capacity issues.

As time progresses, we might have to go back to analyse the root cause. Is notified body capacity the real issue here or are other, underlying developments causing this slow implementation?

Lots of guidance documents have been produced, but their focus mainly is on processes. Product specific guidance, that could answer the crucial question “what is sufficient?” have not been developed (yet).

Voices are expressing pros and cons of continuing the current system. Or is it better to move into a more centralized system of market access and could this result in more predictable timelines, attention for SMEs, support for orphan devices, stimulating innovation, and a more agile drafting process of product relevant guidance? Others advocate keeping the implementation on track, as shifting focus will only cause more delays, potentially at the risk of patient care.

This panel will bring various stakeholders from industry, notified bodies and authorities together to exchange views on the best path forward, keeping the patient support as the common goal. The format will be a guided panel debate with, if time allows, Q&A interaction with the audience.