<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Unique Device Identification System Draft Guidance Document – Eisner Safety Consultants</title> <atom:link href="https://eisnersafety.com/tag/unique-device-identification-system-draft-guidance-document/feed/" rel="self" type="application/rss+xml" /> <link>https://eisnersafety.com</link> <description>Just another WordPress site</description> <lastBuildDate>Wed, 01 May 2013 02:09:46 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7.1</generator> <item> <title>IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits</title> <link>https://eisnersafety.com/2013/05/01/imdrf-draft-guidance-docs-out-for-comment-udi-3rd-party-audits/?utm_source=rss&utm_medium=rss&utm_campaign=imdrf-draft-guidance-docs-out-for-comment-udi-3rd-party-audits</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 01 May 2013 02:09:46 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[3rd party audit]]></category> <category><![CDATA[3rd Party Audit Process]]></category> <category><![CDATA[3rd party audits]]></category> <category><![CDATA[Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers]]></category> <category><![CDATA[Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers Guidance Document]]></category> <category><![CDATA[CDRH]]></category> <category><![CDATA[core concepts]]></category> <category><![CDATA[draft guidance document]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[FDA Guidance]]></category> <category><![CDATA[fundamental concepts]]></category> <category><![CDATA[GHTF]]></category> <category><![CDATA[global harmonization]]></category> <category><![CDATA[Global Harmonization Task Force]]></category> <category><![CDATA[global standards]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Health Canada]]></category> <category><![CDATA[IMDRF]]></category> <category><![CDATA[IMDRF Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers]]></category> <category><![CDATA[IMDRF Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers Guidance Document]]></category> <category><![CDATA[IMDRF Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers]]></category> <category><![CDATA[IMDRF Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers Guidance Document]]></category> <category><![CDATA[IMDRF UDI System for Medical Devices (Version 2.0) Guidance Document]]></category> <category><![CDATA[IMDRF UDI System for Medical Devices Guidance Document]]></category> <category><![CDATA[International Medical Device Regulators' Forum]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[medical device regulators]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[national differences]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers]]></category> <category><![CDATA[Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers Guidance Document]]></category> <category><![CDATA[regulatory authorities]]></category> <category><![CDATA[regulatory authority]]></category> <category><![CDATA[third party audit]]></category> <category><![CDATA[Third Party Audit Process]]></category> <category><![CDATA[third party audits]]></category> <category><![CDATA[UDI]]></category> <category><![CDATA[UDI System]]></category> <category><![CDATA[UDI System for Medical Devices]]></category> <category><![CDATA[UDI System for Medical Devices (Version 2.0)]]></category> <category><![CDATA[UDI System for Medical Devices (Version 2.0) Guidance Document]]></category> <category><![CDATA[UDI System for Medical Devices Guidance Document]]></category> <category><![CDATA[Unique Device Identification System]]></category> <category><![CDATA[Unique Device Identification System Draft Guidance Document]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3311</guid> <description><![CDATA[The International 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]]></description> <content:encoded><![CDATA[<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">The International 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 Regulated product submission (RPS) Table of contents.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">So, what are the guidance documents and the deadlines to provide feedback to the IMDRF?</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span id="more-3311"></span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">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> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">First, let’s look at the </span><strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.eisnersafety.com/wp-content/uploads/2013/04/UDI-System-for-Medical-Devices-Version-2.0-10Apr2013.pdf" target="_blank" rel="noopener noreferrer">UDI System for Medical Devices (Version 2.0)</a></strong><span style="font-family: arial, helvetica, sans-serif; font-size: small;">. The GHTF issued a version of this guidance back on 16 Spet 2011. The IMDRF document clarifies and supplements the GHTF document. From the introduction the Guidance document tells us:</span><span style="font-size: small;"><span style="font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif;"> “</span></span><span style="font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">This guidance provides a framework for those regulatory authorities that intend to develop their</span><span style="line-height: 18px;"> own UDI Systems…In order to reach the goal of a globally harmonized UDI System, it is critical that these systems are implemented without regional or national differences. This guidance is intended to provide a high-level conceptual view of how a global UDI System should work.” It goes on to say that additional guidance may be needed once the core concepts are implemented.</span></span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">The Guidance goes on and indicates that there are 7 fundamental concepts of a globally harmonized UDI System and includes:</span></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">the UDI and UDI Carrier are based on global standards</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span style="line-height: 18px;">a UDI applied to a medical device anywhere in the world should be able to be used </span><span style="line-height: 18px;">globally to meet the UDI requirements of any regulatory authority</span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">national or local identification numbers should NOT be a substitute for UDI</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">regulatory Authorities should not specify how to modify these standards</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">the UDI Database (UDID) core elements should not be modified</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">the UDID should use the HL7 SPL for data submission</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;">each medical device needs to be identified by a UDI</span></li> </ul> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Comments are due by 31 July 2013. If you want to submit comments please use either of the comment templates <strong><a href="http://imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-comments-130418.doc" target="_blank" rel="noopener noreferrer">Comments template – DOC (32kb)</a></strong> or <a href="http://imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-comments-130418.pdf" target="_blank" rel="noopener noreferrer"><strong>Comments template – PDF</strong> (56kb)</a>. They ask that the comments are sent to <strong><a href="mailto:EC-IMDRF2013-SECRETARIAT@ec.europa.eu">EC-IMDRF2013-SECRETARIAT@ec.europa.eu</a></strong>.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Let’s look know at the other documents of interest which are a set of 2 documents that are related to the Third Party Audit Process. These two guidances aim to establish a common set of criteria for medical device auditing and monitoring organizations and the competency of their employees.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">The first of the series of two guidance documents we will look at is the draft guidance on <strong><a href="http://www.eisnersafety.com/wp-content/uploads/2013/05/Recognition-and-Monitoring-of-Organizations-undertaking-Audits-of-Medical-Device-Manufacturers-5-Apr-2013.pdf" target="_blank" rel="noopener noreferrer">Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers</a></strong><span style="line-height: 18px;"> issued on 5 April 2013 with comments being due on 14 June 2013. The guidance says “IMDRF developed this document to encourage and support global convergence of regulatory systems.” The document goes on to say that the concept was first addressed by the GHTF and “IMDRF seeks to further the work of the GHTF in this document by providing a common set of criteria to be utilized by the Regulatory Authorities for the recognition and monitoring… of entities that perform audits…” “The functions covered by an Auditing Organization, within the scope of this document, and roles assigned are described” below:</span></span></p> <p style="padding-left: 30px;"><span style="font-size: x-small; font-family: arial, helvetica, sans-serif;"><strong>Functions Audits On-site Audit/Decision Off-site</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;">Conduct assessment application review n/a Program administrator</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> to determine audit team competence</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> required, select the audit team members,</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> and determine audit duration</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;">Assessment of quality management Lead Auditor/Auditor n/a</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> system</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;">Assessment of product related Technical Expert n/a</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> technologies</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;">Assessment of Technical Files Technical Expert n/a</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;">Assessment of Regulations Lead Auditor/Auditor/ Final Reviewer/</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"> Technical Expert Technical Expert</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Comments are due by 14 June 2013. If you want to submit comments please use either of the comment templates <strong><a href="http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-audit-recognition-comments-130418.pdf" target="_blank" rel="noopener noreferrer">Comments template – PDF (31kb)</a></strong> or <strong><a href="http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-audit-recognition-comments-130418.doc" target="_blank" rel="noopener noreferrer">Comments template – DOC (54kb)</a></strong>. They ask that the comments are sent to <span style="line-height: 18px;">the Medical Device Single Audit Program (</span><span style="line-height: 18px;">MDSAP) Working Group Chair, <strong><a href="mailto:Kimberly.Trautman@fda.hhs.gov">Ms. Kim Trautman</a></strong> and </span><span style="line-height: 18px;">with a copy to the <strong><a href="mailto:IMDRF.Secretariat@tga.gov.au">IMDRF Secretariat</a></strong>.</span></span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">The second in this series of draft guidance documents is titled <strong><a href="http://www.eisnersafety.com/wp-content/uploads/2013/05/Auditor-Competency-and-Training-Requirements-for-Organizations-undertaking-Audits-of-Medical-Device-Manufacturers-31-Jan-2013.pdf" target="_blank" rel="noopener noreferrer">Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers</a></strong>. It was issued on 31 January 2013 with comments due by 14 June 2013. The draft guidance states “<span style="line-height: 18px;">The purpose of this document is to specify competency requirements that shall be demonstrated </span><span style="line-height: 18px;">and maintained by recognized Auditing Organization for personnel involved in medical device </span><span style="line-height: 18px;">regulatory audits and decision making.” The document is “for personnel involved in audits and decision making functions for assessing conformity with regulatory requirements for medical device manufacturers, and includes:</span></span></p> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Defining knowledge, skills, and abilities</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">Criteria for various degrees of competency based on roles in audits and decision making </span><span style="line-height: 18px;">functions</span></span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Assisting in evaluation and development</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Providing a basis for identifying training needs</span></li> </ul> <div><span style="font-size: small; font-family: arial, helvetica, sans-serif;">It goes on to say “<span style="line-height: 18px;">Adherence to this document and its requirements </span><span style="line-height: 18px;">will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by </span><span style="line-height: 18px;">ensuring that Auditing Organization personnel have the necessary commitment, competency, </span><span style="line-height: 18px;">experience, and training before conducting an audit or undertaking a decision making function.” The document relates to the functions performed by an Auditing Organization and for the assigned roles as described in Table 1 of the document which is very similar to the table earlier in this post.</span></span></div> <div><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Comments are due by 14 June 2013. If you want to submit comments please use either of the comment templates <strong><a href="http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-auditor-training-comments-130418.pdf" target="_blank" rel="noopener noreferrer">Comments template – PDF (31kb)</a></strong> or <strong><a href="http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-auditor-training-comments-130418.doc" target="_blank" rel="noopener noreferrer">Comments template – DOC (54kb)</a></strong>. They ask that the comments are sent to the Medical Device Single Audit Program (MDSAP) Working Group Chair, <strong><a href="mailto:Kimberly.Trautman@fda.hhs.gov">Ms. Kim Trautman</a></strong> and with a copy to the <strong><a href="mailto:IMDRF.Secretariat@tga.gov.au">IMDRF Secretariat</a></strong>.</span></div> <div><span style="font-family: arial, helvetica, sans-serif; font-size: small;">If we can be of any help for your company please let us know we would be happy to discuss these documents with you and help by providing consulting services to help with your quality systems or other requirements you may have.</span></div> ]]></content:encoded> </item> </channel> </rss>