Insights on Upcoming Revisions to ISO 13485

Regulatory NewsRegulatory News | 22 October 2018 |  By 

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to the global standard for quality management systems (QMS), ISO 13485.
The outcome statement from the September IMDRF meeting in Beijing, China points to a decision made by the management committee to issue a position statement to the International Organization for Standardization (ISO) on a proposed revision of ISO 13485. 
The transition period for device manufacturers across the countries that recognize the standard to update their QMS to comply with requirements under the third edition, ISO 13485:2016, is set to last until February 2019 after which the 2003 version will be withdrawn. ISO standards typically undergo a technical management board’s (TMB) systematic reviews every five years.
But the lifecycle of ISO 13485 will differ. “The ISO TMB has shortened the timeline for a systematic review from five years to three years for ISO 13485:2016,” Wil Vargas, director of standards at the Association for the Advancement of Medical Instrumentation (AAMI) told Focus. Under the new timeline, 13485:2016 is up for systematic review in February 2019, Scott Sardeson, international regulatory affairs and quality compliance leader at 3M, told Focus. Vargas and Sardeson are members of the technical committee ISO/TC 210 WG 1 and have been following IMDRF’s work.
“With the upcoming systematic review scheduled for 2019, the ISO TMB has asked ISO/TC210 to look at a revision of ISO 13485:2016 so that it conforms to the ISO High Level Structure (HLS), which is an ISO requirement for all management system standards,” added Vargas, who also serves as the secretary of ISO/TC 210.
“Different national bodies and global stakeholder groups have met to discuss the possible impact an HLS-focused revision may have on ISO 13485 and the industry as a whole and have put forth a ‘position statement’ so it may be considered by ISO/TC210 and the ISO TMB,” said Vargas. Sardeson posted a two-part survey online for feedback on adoption of ISO 13485:2016.
IMDRF was asked to state its position as to whether to maintain ISO 13485:2016 and the pending position statement could go one of two ways, according to Sardeson. The IMDRF management committee could leave “as is for the next 5 years or desire to revise it,” he noted.
Kim Trautman, executive VP of medical device international services at NSF International, noted that the need for a position statement to come from IMDRF relates to the fact that ISO 13485 is a standard used for regulatory purposes by different agencies worldwide.
The IMDRF position statement will also clarify “when and how the next version of ISO 13485 might be and any concerns about the ISO Quality Standards” HLS or Annex SL “can or cannot be incorporated depending upon planned HLS revisions,” Trautman told Focus.
The final document on optimizing standards for regulatory use was also posted on the IMDRF website on Monday, following the meeting in Washington last week. Other outcomes from the September meeting, including three newly approved work item proposals for harmonization of cybersecurity terminologies, regulatory pathways for personalized devices and premarket reviews, among others, were discussed during AdvaMed’s MedTech Conference last month.
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration, also noted at the September conference that IMDRF has agreed to be more transparent with member agencies' adoption of final documents and to put in place the building blocks to establish a new medical device single review program. CDRH is also proposing revisions to ISO 13485 partly for an overhaul of its current quality system regulation—a move with ISO’s and industry support—as part of the efforts for global harmonization. 


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