MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

In a letter to the ISO 13485 working group, the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) raised concerns over a systematic review of ISO 13485 set for early 2019.
 
MDSAP RAC chair David Boudreau’s argument against conducting a systematic review of the third edition of the global standard for quality management systems (QMS) is largely centered on three points. These relate to MDSAP’s format, QMS overhauls and regulatory authorities.
 
Another concern relates the International Standardization Organization’s (ISO) systematic review of 13485 set to take place in February 2019 as medical device manufacturers will have just completed transitions to the standard’s 2016 version, noted Boudreau, who also serves as executive director at Health Canada’s Medical Devices Bureau.
 
The MDSAP format maps out ISO 13485:2016 requirements so that these can be satisfied across the five jurisdictions participating in the consortium by participating manufacturers.
 
“If changes are implemented to ISO 13485:2016, the audit model for MDSAP, which was just recently revised, will have to be completely revised, training of the Auditing Organizations will need to be conducted, and transition periods will need to be implemented leading to instability in the MDSAP at a critical time,” Boudreau argued in the 5 November letter.
 
Boudreau also pointed to ongoing plans among several of the regulatory authorities that comprise the MDSAP consortium. These involve two agencies that have already begun transitioning away from their existing QMS requirements to ISO 13485:2016—Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)— and the US Food and Drug Administration’s (FDA) intent to transition its quality system regulation to the ISO standard.
 
The letter comes after the rationale for taking up the ISO High Level Structure (ISO HLS) two years earlier than the 5-year lifecycle that was agreed upon in ISO 13485:2016’s publication were revealed last month, following the release of the outcome meeting statement from an earlier International Medical Device Regulators Forum (IMDRF) management committee meeting. It also follows on the heels of the liaison IMDRF members inked with ISO/TC 210—aimed at ensuring new or revised standards are deemed acceptable by IMDRF.
 
The IMDRF management committee agreed to issue a position statement to ISO on the proposed revisions to 13485:2016 during the last IMDRF meeting in China. It remains unclear whether the agreement was reached prior to learning about the upcoming revisions. Whether or not the pending HLS revisions can be incorporated and to what extent will be clarified in the position statement that will come from IMDRF, NSF International’s Kim Trautman previously told Focus.
 
The MDSAP RAC understands 13485:2016 is “based on the format of the previous edition (2003) and ISO 9001:2008 and does not currently follow” ISO HLS “as outlined in Annex SL of the ISO/IEC Directive Part 1” yet the HLS “introduces concepts and potentially requirements that fall outside the purview or the authority of regulatory authorities,” Boudreau cautioned in the letter to the ISO working group.
 
“This could lead to regulators needing to either exclude portions of the standard from regulatory requirements, or to develop their own version of the standard that exclude the objectionable concepts and requirements,” he added.
 
MDSAP plans
 
The plans and vision for how to expand on the MDSAP model have continued to evolve since it was established as IMDRF’s cornerstone initiative a few years ago, despite several remaining barriers facing participating companies and auditing organizations. Health Canada said late September it is anticipating some manufacturers to discontinue their device sales in the Canada market to avoid facing the MDSAP requirements that will become mandatory next year.
 
But similar to the growing momentum around MDSAP participation among companies, an increasing number of countries have joined the movement around international harmonization of medical device regulations via IMDRF. In addition to FDA, Health Canada and Japan’s PMDA, other agencies in the MDSAP consortium include Australia's Therapeutic Goods Administration (TGA) and Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA).
 
A major development involving MDSAP relates to the intentions at FDA’s Center for Devices and Radiological Health to base its QMS transition on the global regulatory auditing model.