Final stretch to MDR/IVDR implementation: How are companies revising their strategy to comply with the key requirements and associated timelines?

EU new regulations are introducing an enhanced framework around the definition, supervision, traceability and risk-based classification system for medical device equipment. They will shortly apply after a transitional period: May 2020 for the medical devices and May 2022 for in-vitro diagnostic medical devices. How has the upcoming deadline impacted the MedTech and diagnostic players both from a European point of view and for foreign companies conducting business in Europe? What long term implications may this new legislation have on innovation and market investment? How are companies and regulatory authorities dealing with the remaining uncertainties?