Regulators participating in the International Medical Device Regulators Forum (IMDRF) recently convened in Tokyo to discuss a medical device single review program (MDSRP).
The meeting involved the IMDRF good regulatory review practices (GRRP) working group, which took up medical device premarket reviews as a new work item after the September 2018 management committee meeting in Beijing. An “important document” for MDSRP was discussed and “unanimously recognized” by the participants, according to China’s Center for Medical Device Evaluation (CMDE).
The new document titled the “Recognition Requirements and Procedures for Pre-marketing Evaluation of Medical Devices” relates to the third-party evaluation organizations that would be needed to pursue MDSRP. IMDRF member countries include the US, Europe, Canada, Australia, Singapore, Japan, China, South Korea, Russia and Brazil—all of which have different approaches to premarket evaluations. MDSRP would be a major undertaking for IMDRF, though it has been years in the making.
Interest in a program like MDSRP involves earlier patient access to devices across multiple jurisdictions, which would rely in whole or in part on submissions for approvals or clearances. Industry implications relate to the potential cost savings and reduced regulatory burden that could be achieved through a program like MDSRP. The potential risk to user health, however, would also be introduced on a larger scale.
The GRRP working group developed the IMDRF proposed document from 2016 on competence, training and conduct requirements that is intended to serve as a tool for a consistent, harmonized approach to device evaluation among regulatory authorities or designated conformity assessment bodies. This IMDRF document has yet to be finalized, but a string of other documents that would also play a role in MDSRP were finalized last year. These relate to essential principles of safety and performance, the IMDRF Table of Content (ToC) structure and the regulatory product submission (RPS) beta testing report…