Why was ISO 13485 to be revised so soon?
The last ISO 13485 revision was published in 2016 and the transition period for migration to this version ended in March 2019.
Even before that transition period had ended moves were being made to revise the standard. Following consultation with interested parties in November 2018, a decision has now been made by the relevant Technical Committee, ISO/TC 210, to initiate work of a new revision early in 2019 (2 years ahead of the normal 5-year review). Since then, nothing. Not even a Committee Draft has been developed.
So, what went wrong?
What Changed in the Recent ISO 13485 Revision?
Initially, we believe the initial intention was to focus on the adoption of the ISO 9001:2015 structure to simplify the use of the medical device standard. Then other significant changes in the regulatory field exploded the size and complexity of the task.
While emphasising that we are in the field of speculation, there are a number of serious issues that need to be addressed but still, in 2021, many of these have yet to be finalised or to have their effectivity dates and transition periods finalised. These include:
- The High-Level Structure - HLS – A switch to the HLS would ease the implementation and maintenance of a QMS meeting both ISO 9001 and ISO 13485 requirements. There has been much criticism about the structure of the 2016 standard retaining, as it did, the structure of the ISO 9001:2008 standard.
Working to ISO 13485:2016 for medical device sector customers, and to ISO 9001:2015, with its HLS – High-Level Structure – for their other customers creates a needless additional administrative burden. And, frankly, it was a waste of time.
- EU MDR and IVDR – The Annexes of the 2016 standard relate to EU Directives that are currently being phased out. New Annexes that address the 2017 Regulations are needed. Additionally, the timetable and other details for the implementation of the EUDAMED Medical Device database including, as it does, a medical device ID system have yet to be finalised.
- The simultaneous publication date for the International and EN version of the standard – with both versions having the same publication date, the suggestion that the difference between the two versions goes beyond the addition of Annexes to the EN version is eliminated. Confusion for those unfamiliar with the standard (e.g. those preparing tender documents or letter of credit documents) is consequently reduced.
- MDSAP compatibility – Canada Health implemented MDSAP – the Medical Device Single Audit Programme – early in 2019, and the US FDA and others are working diligently towards adopting it also. Streamlining the Programme requirements with those of ISO 13485 would seem of obvious benefit.
- Maintain IMDRF acceptance of ISO 13485 – The International Medical Device Regulators Forum – IMDRF – is a global body of regulators who were the instigators of the MDSAP and of the incorporation of ISO 13485 into that Programme. There is a need for the ISO/TC to ensure ongoing acceptance by the IMDRF of any proposed ISO 13485 changes.
- And then there is China. It accounts for over 50% of the world market for medical devices. Their regulatory input, like that of other significant global regulators, will have to be considered.
Implications of the Revision on ISO 13485 Implementation
And yet we don't consider the changes to be brought about by the next revision will be too onerous.
The changes are likely minimal regarding processes, procedures and record-keeping. The rewriting/restructuring of Quality Manuals, quality policy statements, medical device files, risk management files and the like will be necessary. Overall, it's not likely to be highly disruptive to day-to-day operations of ISO 13485 or of joint ISO 13485/ISO 9001 QMS, for whom life should get easier.
And why are we interested?
As providers of ISO 13485 ISO Auditor online training courses, we are going to have to revise all eight of our Courses for what we expect will be radical changes to requirements with consequential disruption to our other product development plans.
We hope that the revision to ISO 13485 will proceed smoothly - it's now 5 years since the publication of the last revision and an update is due. We will watch developments with interest. With so much change in the world of medical device regulations at present, we hope the next revision won’t add to the burden.
Note: First published in Dec 2018; revised and updated in May 2021.