Does your quality system meet the additional requirements?
New EU regulations for medical devices come into full application by May 2020. The parallel regulations for IVDs apply from 2022. This particularly affects those organizations that may have not been previously been subject to regulation (e.g., distributors, importers) and those for whom the regulatory requirements have increased (manufacturers, authorized representatives). Medical device organizations must have an adequate quality management system in place to maintain access to the EU market and other markets that recognize EU authorizations. They need to designate a person that is responsible for regulatory compliance with defined responsibilities. The interactions of organizations in the supply chain need to be managed within a quality management system.
This webinar will provide you the information to determine the requirements for your organization and the steps you need to be taking to ensure compliance before the date of application in 2020/2022.