Please note that a separate fee is required to attend this pre-conference workshop and is not included in the main registration for the 2021 Euro Convergence. If you have already registered for the conference and would like to add this workshop, please contact firstname.lastname@example.org or log in to the registration system and modify your registration. Registration for preconference workshops closes on 5 May at 23:59 CEST CLICK HERE TO REGISTER
One of the biggest challenges posed by the EU MDR is the requirement to substantiate market access of medical devices with ’sufficient' clinical data. Manufacturers ask themselves the question: How can I effectively and cost-efficiently obtain the required clinical data? Clinical data derived from medical devices already on the market can be an important source. This session will give you the background and insight to decide in what cases a Post Market Clinical Investigation will be a suitable source of clinical data. The session will also explain the design and the legal requirements and procedures for Post Market Clinical Investigations in the MDR.