The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements. Submissions for CE marking under the new MDR will need to satisfy more demanding clinical data requirements. Long-established devices on the market will not be exempt. For many devices, new data will have to be generated or collected retrospectively. How can manufacturers ensure they will have sufficient...