2019年 8月 13日
The International Medical Device Regulators Forum (IMDRF) has published recommendations to establish more specific criteria whereby market regulators recognize conformity assessment bodies (CABs) for conducting premarket reviews of devices and IVDs.
The recent IMDRF draft guidelines are part of the organization’s broader efforts to develop a “common set of requirements to be utilized by the Regulatory Authorities for the recognition and monitoring of entities that perform regulatory reviews and other related functions,” according to the document. IMDRF plans additional guidance in relation to CAB recognition and related premarket review issues in the future.
IMDRF is accepting comments on the proposed CAB recognition requirements through October 3, 2019.
In an effort to establish a more uniform process for CAB premarket review of device and IVD submissions across multiple markets, the new IMDRF document includes specific premarket application review and certification decision processes CABs should implement and conduct in order to achieve and maintain recognition from regulators.
The IMDRF proposed approach would keep the ISO/IEC 17065:2012 standard (Conformity assessment – Requirements for bodies certifying products, processes and services) as a generic baseline for CAB recognition requirements, supplemented with more specific requirements in the new document.
IMDRF requirements more targeted at device CABs are broken down into several categories, such as:
In addition, the IMDRF document covers requirements for how CABs should organize their management structures and staffing. These requirements include keeping staff up to date on current medical device and IVD regulations, technologies and best practices; establishing codes of conduct; and adhering to IMDRF recommendations for regulatory reviewer competence and training.