The MDR and IVDR represent significant changes to European legislation for medical devices and in vitro diagnostic medical devices (IVDs). One significant new requirement is that manufacturers and authorized representatives for both medical devices and IVDs appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS), regulatory documentation, post-market surveillance and vigilance reporting, and devices used for clinical investigation.
Download our guide to learn more about the background to the EU rules regarding responsible persons and the actions your organization may need to take as a result of them. This guide is an excerpt from the Smart Support series: a series of topic-specific expert commentaries on the MDR/IVDR. These have been made available exclusively to Compliance Navigator customers to help them interpret the new Regulations accurately.
