{"id":3311,"date":"2013-05-01T02:09:46","date_gmt":"2013-05-01T02:09:46","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3311"},"modified":"2013-05-01T02:09:46","modified_gmt":"2013-05-01T02:09:46","slug":"imdrf-draft-guidance-docs-out-for-comment-udi-3rd-party-audits","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/05\/01\/imdrf-draft-guidance-docs-out-for-comment-udi-3rd-party-audits\/","title":{"rendered":"IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits"},"content":{"rendered":"

The \u00a0International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the GHTF left behind when it was decommissioned in the last. In another post I will follow-up on one other draft guidance document which is on the\u00a0Regulated product submission (RPS) Table of contents.<\/span><\/p>\n

So, what are the guidance documents and the deadlines to provide feedback to the IMDRF?<\/span><\/p>\n

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WARNING; It is critical to be aware that each comment template is specific to a specific draft guidance document and if you don’t use the proper one your comments could be skipped over or not aligned with the proper guidance document and you would then not have your comments covering what you are commenting on so be careful and double check on the IMDRF website as they may update the documents and this post will not go back and update these links.<\/span><\/p>\n

First, let’s look at the <\/span>UDI System for Medical Devices (Version 2.0)<\/a><\/strong>. \u00a0The GHTF issued a version of this guidance back on 16 Spet 2011. \u00a0The IMDRF document clarifies and supplements the GHTF document. From the introduction the Guidance document tells us:<\/span> “<\/span><\/span>This guidance provides a framework for those regulatory authorities that intend to develop their<\/span>\u00a0own UDI Systems…In order\u00a0to reach the goal of a globally harmonized UDI System, it is critical that these systems are\u00a0implemented without regional or national differences. This guidance is intended to provide a\u00a0high-level conceptual view of how a global UDI System should work.” \u00a0It goes on to say that additional guidance may be needed once the core concepts are implemented.<\/span><\/span><\/span><\/p>\n

The Guidance goes on and indicates that there are 7 fundamental concepts of a globally harmonized UDI System and includes:<\/span><\/p>\n