Developed in response to high-profile devices that resulted in patient injury or death, the European Union’s (EU) new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) replaces the previous EU Directives dating from 1993 (MDD) and 1998 (IVDD), respectively. Unfortunately, a lack of supporting resources (e.g., Notified Bodies, EUDAMED, etc.) and implementation guidance has caused regulators to push back mandatory compliance deadlines to avoid critical device shortages.
Due to patient safety concerns, the resulting regulations were more proscriptive than would otherwise be the case. The cost of this proscriptive regulation is substantial: manufacturers report a 10-times cost increase to register legacy devices under the MDR (vs. MDD), attributed to clinical data, post-market surveillance, and labeling requirements.
The tension between desired effect (patient/user safety) and undesired expense is best illustrated by a new class of documentation required by the MDR: Summary of Safety and Clinical Performance (SSCP) and IVDR: Summary of Safety and Performance (SSP).
This white paper discusses how automation technologies, including specialized AI, can streamline content management and translation processes to meet the growing demands of the MDR and IVDR. Specifically, the paper explores the challenges posed by increased content requirements, such as labeling, marketing materials, SSCPs, SSPs, and clinical communications, and the limitations of manual processes using applications like Microsoft Word and InDesign.
Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance by downloading the paper.