IMDRF Takes Another Stab at IVDs, MDSAP

Regulatory NewsRegulatory News | 25 April 2019 |  By 

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate.

A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP is also under development.

The goal of the new IVD WG is to revise a document the defunct Global Harmonization Task Force (GHTF) finalized in 2008 prior to being replaced by IMDRF, Melissa Torres, associate director for international affairs at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), said during a Wednesday session at the AAMI/BSI/FDA International Conference on Medical Device Standards and Regulations.

Revisions to GHTF SG1/N045: 2008 Principles of IVD Medical Devices Classification will address new technologies and approaches to IVDs’ risk-based classification process, added Torres, who also serves as chair of the IMDRF Good Regulatory Review Practices Group (GRRP). ""We know a lot has been evolving in the past 11 years`and so the document needs to be updated," Torres said. The WG will be chaired by Russia, which is the current chair of IMDRF. 

IMDRF now has a total of seven active WGs, down from the eight WGs it had before closing one on unique device identification last month because the work was completed.

MDSAP Expansion

Torres said the IMDRF management committee has also agreed to explore ways to create a new MDSAP category of membership for more than the existing participating countries to use aspects of the harmonized auditing program, rather than adopting it in its entirety. MDSAP has continued to see steady growth since the initiation of its pilot phase in 2014. Torres explained how more and more countries have expressed interest in MDSAP, but may not necessarily have the appropriate resources in place to implement the full program.

"We have not opened it further for other countries at this time because we are still trying to work through a lot of kinks in the program itself," said Torres. "Adding a country means revising the entire audit model, which then increases the length of the audit and length of the audit is something we've been criticized about already so there has to be a balance." She added that a key factors is that every participating country has to have a confidentiality agreement with each other and this presents some challenges so in other countries that do not.

IMDRF intends to publish the category of MDSAP membership in upcoming weeks. This will encourage other countries to use MDSAP audit reports, according to Torres. "We certainly have received a lot of interest from other countries not participating," but more work needs to be done to address some remaining issues first.  

MDSAP saw significant new growth earlier this year, following Health Canada’s mandatory transition.

CDRH program manager Marc-Henri Winter noted that a total of 879 device manufacturing sites were added during Q1 2019, bringing the cumulative total to 4,095 MDSAP participating facilities.


But the US does not intend to make MDSAP participation mandatory as Canada did. Health Canada was reportedly purposeful in deciding to set the January deadline to complete the MDSAP transition and the mandatory transition to the 2016-revised version of ISO 13485 so that manufacturers can combine both transitions.

Health Canada had already anticipated some manufacturers to cancel their previously approved medical device licenses over its decision to make MDSAP certificates requirements to legally sell medical devices on the Canada market. There were about 3,400 Canadian device license holders prior to the MDSAP transition, 83% of manufacturers transitioned and 96% of licenses were retained, according to Winter.

Winter touted regulators’ engagement with auditing organizations and partner countries as one of the successes of MDSAP. Yet barriers to program development remain, including Canada’s mandatory transition. Such challenges also include manufacturer buy-in, the time and cost of an audit, resource limitations and changes to ISO 13485 for required conformity to the International Organization for Standardization’s High Level Structure, Winter said. The revisions to the standard on quality management systems also pose challenges around FDA’s forthcoming proposed rule to transition from its quality system regulation toward 13485:2016. But experts say industry should not worry.


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