The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization.
Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thursday.
Wil Vargas, secretary of the technical committee responsible for the 13485 revision, noted in an interview with Focus
that the revision
was needed for the first time in 13 years to incorporate work that most medical device manufacturers were already implementing. Vargas argued the transition period was important, particularly for international device companies, as not all fell into this category.
“There is a lot going on with 13485 these days,” Vargas said, noting the new regulatory requirements in several different countries and its role in a growing audit program.
The 2016 revision for 13485 placed more emphasis on quality management systems (QMS) across the entire supply chain and is intended to address the total product lifecycle of medical devices, among other changes to the previous edition. Implications for manufacturers differ depending on the jurisdiction in which they seek to operate and market medical devices.
Australia, Canada, EU, US
Australia’s Therapeutic Goods Administration (TGA) posted
a notice on Friday to explain the new situation facing manufacturers that rely on 13485 compliance to demonstrate conformity with the QMS requirements of Australia’s conformity assessment procedures. All TGA audits began being conducted against the 2016 edition at the beginning of January and from Friday, submitting evidence that a 13485:2016-compliant QMS has been implemented is required to support conformity assessment applications.
Similarly, Health Canada set
transitioning to the revised standard by 1 March as mandatory for all manufacturers of class II, III and IV medical devices. And it has not accepted Canadian Medical Devices Conformity Assessment System certificates since last December. This came after medical device manufacturers in the Canada market faced an aggressive timeline when Health Canada required them to transition into the Medical Device Single Audit Program (MDSAP) and submit valid MDSAP certificates to the regulator no later than 1 January.
“With the Health Canada required transition to MDSAP as of 1 January 2019 (with some provisions for extensions), the transition to ISO 13485:2016 has been a relatively smooth one,” NSF International’s Kim Trautman told Focus
. She noted that the decision Health Canada reported in 2016 on the required MDSAP transition also informed of the required 13485 transition. This was a purposeful decision of the regulator to allow manufacturers to combine the transitions and “appropriately strategize,” she said.
The EU has been undertaking a regulatory overhaul since 2017. The medical device regulation (MDR) and in vitro
diagnostic regulation (IVDR) began requiring adherence to the revised 13485:2016 this month, though MDR and IVDR will not come into full effect until 2020 and 2022. The transition period for 13485:2016 was thus also critical since “not all had three years to get done as much as possible because auditing organizations and Notified Bodies have a whole bunch on their plate to include the continuation of the EU device directives and getting prepared for MDR,” Trautman said. She argued the 13485 transitions seem to be going well due to alignment with others, such as MDSAP and MDR/IVDR.
Compliance with 13485:2016 is not a US Food and Drug Administration (FDA) requirement for medical device manufacturers to operate and market within the US. But those that have yet to mind the new edition should consider how the trend toward international harmonization has picked up steam in recent years. MDSAP demonstrates the momentum as a growing body of device firms seek relief by meeting requirements across several jurisdictions.
FDA, meanwhile, has been working
on a blend of the current Quality System regulation and 13485:2016. It discussed these plans last year, with a set
action date of April 2019. FDA intends
to leverage MDSAP.
“The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” FDA said. This is in line with FDA efforts around reduced regulatory-related burden via greater global harmonization using programs such as MDSAP—a cornerstone of the International Medical Device Regulators Forum (IMDRF). FDA, Health Canada, TGA and the European Commission all form part of the IMDRF management committee along with six other global regulators.
FDA has yet to specify how it intends to review the regulation, though it tapped
the Association for the Advancement of Medical Instrumentation (AAMI) to jointly develop an AAMI technical information report (TIR). Those that transitioned to 13485:2016 will be better positioned with FDA’s initiative.
“If they are already aligned with the 2016 version, they are about 90% there and it's really not a big deal,” said Vargas, who also serves as the AMMI standards director. This was echoed by Trautman, who authored the current version of 21 CFR Part 820 while she served as an FDA official prior to joining NSF.
Trautman told Focus
that there was no 13485 when she wrote the current version of 820 or any other international sector-specific standard to rely on. Each version of the standard since its inception in the 1990s has brought greater regulatory convergence, she said. Trautman added that the convergence spread not just with FDA and 13485, but also with Brazil, Japan, Europe, among several other nations.
She argued that manufacturers should not be worried about FDA’s initiative. "FDA has the right intention to continue to strive and move towards that convergence and in fact it makes 820 better by incorporating some of the things that 13485 was able to add in overtime,” Trautman said. Risk management and the separation between corrective action and preventive action are some examples.
AAMI is currently focused on developing the TIR to connect the dots between FDA’s 21 CFR Part 820 and the current 2016 edition of the standard 13485, Vargas said. The work involves comparing 13485 against the existing regulations and vice versa for the TIR to serve as a transitional document to aid industry with the shift, according to Vargas. AAMI intends to publish this TIR in the coming months.
ISO 13485:2016 is set to undergo revisions to conform with the ISO High Level Structure (HLS), as reported
. This is to reflect HLS terms and definitions, including that of risk. Vargas noted TC 210 WG 1—the working group responsible for 13485—is nearing a decision on the direction of the HLS revisions.
Revising 13485 against HLS is expected to have ripple effects. Vargas argued the most notable issue could potentially involve the impact on FDA’s initiative because changing how core principles, such as risk, are defined in 13485:2016 could have “a real dramatic impact to the way that the document is laid out and understood.”
Yet the initiative has received widespread support, including AAMI’s.
“If FDA decides to go completely with 13485:2016, that will be an unprecedented step for global harmonization,” Vargas argued. “That would be the amazing smash hit of the summer in the sense that it opens the floor for other things to come forward because that paved the way and made it that much easier.”
Another ripple effect relates to the standard’s foundational role
n MDSAP. MDSAP programs have used 13485 since the early 2017 revised MDSAP audit model and the audit model companion document for the revised 13485:2016.
“There is a lot more to an MDSAP audit that just 13485 and in fact more than just QMS,” Trautman noted. “But clearly it is a foundational piece. So the transition between 13485 and Health Canada's decision [on the required transition into MDSAP] seemed to be a natural one.”