Hello Anon,
ISO standards do not generally have a transition timeline; they are effective upon publication date. Some of the management system standards, e.g. 9001, 13485, 27001, have three (3) year transition periods. In addition, some international standards including ISO, IEC individual regulatory agencies establish transition periods, e.g. 60601-1, 10993. When a standard like ISO 20417 is published first remember these are "voluntary" or semi-voluntary depending on the regulatory requirements the organisation is trying to meet. If a company claims compliance to an ISO standard like ISO 20417 as part of their instructions for use (IFU) development such as having a reference in the standard operating procedure, then it is expected the company is following the standard. This is being commonly asked in Europe now, so if your technical documentation/GSPR states compliance to ISO 20417, then need to be in compliance. If you do not have ISO 20417 as part of references, then there is the risk of a deficiency or opportunity during a Notified Body audit as standard may be considered current. (I will not get into the whole discussion about harmonised standards and state of the art, just leave at some auditors may expect compliance as it is published.) What this means is like any new or revised standard, create an assessment or gap analysis to understand the impact, establish a quality plan for implementation, and complete tasks against a timeline for when your company would be compliant. An external auditor should not cite any type of observation if the company has a quality plan describing activities, acceptance criteria, responsibilities, and timelines for implementation.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Jan-2022 12:20
From: Anonymous Member
Subject: Applicability of ISO 20417 standard
This message was posted by a user wishing to remain anonymous
Hi all,
I have a question regarding ISO 20417 applicability, hope you can help.
What is the transition timeline for implementing this standard for new devices?
Also, regarding devices already released before the standard publication date but still shipped: by when would these devices require an update of the technical file to show compliance to ISO 20417?
Thanks!