Oct 30, 2015

The International Medical Device Regulators Forum (IMDRF), the group of major medical device market regulators previously known as the Global Harmonization Task Force or GHTF, has announced plans to focus efforts on improving post-market surveillance and premarket review processes for devices through 2020.

According to the IMDRF’s recently published Strategic Plan 2020, the organization’s high-level objective over the next four years will be supporting “innovation and timely access to safe and effective medical devices,” with a specific focus on areas and markets where few or no common regulatory requirements hinder delivery of devices already available in other markets and jurisdictions. IMDRF members believe that improving post-market surveillance as well as device reviews will help achieve this objective.

Boosting post-market surveillance

The IMDRF will pursue five major work items, some of which have already begun, in order to improve post-market surveillance systems in medical device markets.

These efforts include more effective sharing of post-market data through programs such as the GHTF National Competent Authorities Reports Exchange Program; building common principles for device registries; and establishing more harmonized terminology for adverse events so that such information can be more effectively shared among regulators.

The IMDRF’s ongoing Medical Device Single Audit Program (MDSAP) and its push for wider adoption of Unique Device Identification (UDI) systems among device market regulators would also help the organization improve post-market surveillance processes.

Improving pre-market reviews

More efficient pre-market device reviews depend largely on convergence of review processes among different regulators, argues the IMDRF. The benefits of being able to utilize the same performance and safety data for more than one regulatory review may be self-evident for many manufacturers and market overseers alike, but the IMDRF’s work remains significant in this area.

To address this objective, the IMDRF has already undertaken initial development of that it calls Regulatory Product Submissions for medical devices and IVDs; the organization also plans to look into improving clinical data quality and reliability, best practices for pre-market reviews and more guidance for benefit-risk determinations.


  • Stewart Eisenhart