avaIMDRF
avaIMDRF is the solution for efficient and consistent application of the IMDRF AER codes within your company. Transform the categorization and analysis of safety related data from a potential compliance headache to streamlined, confident processes and consistent documentation.
The international terminology for adverse events
Introduced in 2017 by the International Medical Device Regulators Forum (IMDRF), the Adverse Event Reporting (AER) terminologies are intended for a globally consistent terminology and coding of adverse events in the medical technology industry. The use of the codes is mandatory for the reporting of adverse events to national authorities in the U.S. and in Europe since 2020 and shall be used for data categorization in Periodic Safety Update Reports (PSURs) according to the European Medical Device Regulation and the European guidance MDCG 2022-21.
In order to provide the best possible support for the correct and consistent use of the codes, their application is also recommended for other medial device related processes, such as complaint handling, risk management, clinical evaluation, post-market clinical follow-up (PMCF) and post-market surveillance (PMS).
With over 1,800 codes, keeping them up-to-date and manually filtering relevant codes can be inefficient and error-prone. The manual search for relevant codes can lead to inconsistencies across different processes and related documentation, which may result in a nonconformity during an audit or inspection.
Consistent application across medical device processes
avaIMDRF is the solution for efficient and consistent application of the IMDRF AER codes within your company. Transform the categorization and analysis of safety related data from a potential compliance headache to streamlined, confident processes and consistent documentation. Our solution keeps you up-to-date, compliant, and in control:
- Comprehensive terminology management
Eliminate the complexity of managing extensive AER codes with a centralized, digital database. avaIMDRF provides a single source of truth for your entire organization, ensuring consistent terminology across critical quality management processes. - Efficient code selection and filtering
Assess and document the relevance of the individual codes with regard to your company-specific product portfolio. No more wading through irrelevant terminologies: focus on the codes that matter most to your medical devices and the processes in which you need to use the coding. - Supports processes & seamless integration
Use the AER codes for your digitalized processes in Polarion: The IMDRF AER codes can easily be applied for risk management, clinical evaluation, post-market clinical follow-up and post-market surveillance data and records. - Assured regulatory compliance
Meet the stringent requirements of regulatory authorities and Notified Bodies with confidence. avaIMDRF ensures your technical documentation uses harmonized, up-to-date terminology, reducing the risk of audit nonconformities and their consequences. - Annual data update
Stay current with the latest AER codes: Simply upload the annual updates from the IMDRF website into Polarion to keep your database up-to-date.
- Centralized code management: Maintain a comprehensive overview of 1,800+ IMDRF Adverse Event Reporting codes and their terminologies directly in Polarion
- Company-specific application: Eliminate unnecessary information by evaluating individual codes for their applicability to the company-specific product portfolio
- Cross-process consistency: Ensure uniform terminology usage across different processes and documents, including risk management, clinical evaluation, post-market clinical follow-up and post-market surveillance
- Easy data updates: Seamlessly integrate the latest IMDRF terminology files with simple file uploads into Polarion
- Regulatory compliance: Ensure conformity with regulatory requirements and fulfill international requirements through the consistent application of the AER terminology
