TÜV Rheinland is one of currently five Notified Bodies worldwide (Status: November 19, 2020), offering services throughout your transition to the new IVDR. As a single source provider with a comprehensive range of medical testing and certification services, we can offer you a customized service tailored to your specific products and needs.
In this latest update, TÜV Rheinland and medical device manufacturers are keen to streamline the review of the Technical Documentation as part of initial applications, during surveillance, substantial change notifications, and renewal applications, with the aim to reduce time to certification.
Therefore, we have prepared an IVDR Technical Documentation Guidance document in order to help facilitate and improve the Technical Documentation submission and review process, allowing TÜV Rheinland LGA Products GmbH (TRLP) to issue related certificate(s) under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Do you have any questions about the IVDR? Connect with our experts to find out more.