IMDRF Aims to Balance Data Collection by 2020
The International Medical Devices Regulators Forum has unveiled its strategic plan through 2020 that places a strong emphasis on striking the right balance between pre- and postmarket data collection.
Over the next four years, the forum will undertake initiatives to support innovation and access to safe and effective devices while working toward regulatory convergence, according to the document.
To that end, the management committee will develop new work items to enhance postmarket surveillance and improve the effectiveness and efficiency of premarket review.
The group names work items it has undertaken to enhance postmarket surveillance, such as the establishment of common principles on registries and the creation of the Medical Device Single Audit Program.
IMDRF says it will build on these activities and consider new work items that are in line with these objectives.
In terms of improving the premarket review process, IMDRF is eyeing work items on ensuring the reliability of data submitted to regulatory bodies, improving the quantity and quality of clinical data, developing good review practices to include competence and training for reviewers, creating guidance on risk-benefit determinations and enhancing the suitability of international standards for regulatory authorities and effective regulatory authority involvement at each stage of development.
In addition, the forum will share information on — or challenges to — implementation of outputs in various jurisdictions.
The management committee will develop work plans with timetables for completion, making them available to the public for review.
Finally, IMDRF will continue to enhance transparency and encourage collaboration with stakeholders, including standards development organizations.
The management committee will review progress on the plan and revise it, as appropriate.