NEW MDF13 IVDR introduction for Medical Writers

Description

This workshop introduces the (EU) IVDR 2017/746 from a medical writing perspective. Participants will gain a structured understanding of IVDR’s core components, including intended purpose, device classification, performance evaluation, and post-market follow-up.
Key topics include the scope of IVDR. Special emphasis is placed on the types of documentation that medical writers support (e.g. PEP, PER, PSUR, PMS and PMPF plans). By the end of the session, participants will understand how medical writers contribute to the generation, organization, and presentation of regulatory-compliant documentation for IVDs.