It’s not uncommon for Document Center customers to ask about transition periods — the time that is allowed for compliance when a new edition is released. Happily, some standards do provide you with that information within the document itself. But when there’s no guidance, what’s the proper protocol? Now ISO committee TC84 has issued a new technical report addressing that very issue. It’s ISO/TR 19244, “Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters.” And it’s available now from Document Center Inc. in paper format, for pdf download and as part of our multi-user Standards Online service.
The new document has been written specifically for the TC 84 standards. They cover such things as needle-based injection systems, sharps, aerosol drug delivery systems, needles, syringes, and catheters and ports.
The technical report covers two main concepts:
- Grandfathering – accepting a device meeting the previous edition due to good safety and performance records.
- Transition period – the time that you have to meet the criteria of the new edition for either existing products or products that are about to be released to the marketplace.
Why have a transition period? Of course, with medical devices in particular, the resources necessary to provide new testing and documentation for modifications can be substantial. And in fact, changes may need to be made not only to products and product lines, but also to the criteria for regulatory acceptance.
Of course, no standard can override the particular regulatory requirements of a particular jurisdiction. So you’ll use this document plus the legal protocol for each of the markets where you sell your product(s). However, having general guidance from the Committee is good news for manufacturers in this space.
You’ll need a copy of ISO/TR 19244 in order to understand the committee’s view on the topic. You can purchase your authorized copy from Document Center Inc. on our website, www.document-center.com. Or consider getting in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).
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