The European Union’s new Medical Devices Regulation (MDR), which replaces a decades-old legislation, will require manufacturers to make significant changes in product development, data reporting and their quality management system.
As a result, device manufacturers can expect higher costs and longer timelines for developing new products, as well as costly new clinical monitoring and evidence generation to recertify many existing products, deeply affecting business models of all medical and diagnostic device companies.
With our webinar we would like to provide you with a clear and comprehensive picture about the main changes and challenges faced by manufacturers under the new EU regulations, and how our services will ensure an early compliance which can lead to maximum success.
The webinar will give you details about the most important changes in the MDR:
- Transition period from MDD to MDR – timelines and due dates
- Reclassification of certain devices – new challenges
- New requirements for Technical Documentation
- Clinical testing requirements – sources of Clinical Data for CE Marking
- The mandatory Post-Market Clinical Follow-up
We will provide details about how HungaroTrial can help plan the transition path from MDD to MDR, provide services with planning, managing and reporting clinical trials, and consult you in defining, managing and performing the conformity assessment, leading you to obtain the CE mark for your product.