So, what are the guidance documents and the deadlines to provide feedback to the IMDRF?

WARNING; It is critical to be aware that each comment template is specific to a specific draft guidance document and if you don’t use the proper one your comments could be skipped over or not aligned with the proper guidance document and you would then not have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.

First, let’s look at the UDI System for Medical Devices (Version 2.0).  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: “This guidance provides a framework for those regulatory authorities that intend to develop their 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.

The Guidance goes on and indicates that there are 7 fundamental concepts of a globally harmonized UDI System and includes:

• the UDI and UDI Carrier are based on global standards
• a UDI applied to a medical device anywhere in the world should be able to be used globally to meet the UDI requirements of any regulatory authority
• national or local identification numbers should NOT be a substitute for UDI
• regulatory Authorities should not specify how to modify these standards
• the UDI Database (UDID) core elements should not be modified
• the UDID should use the HL7 SPL for data submission
• each medical device needs to be identified by a UDI

Comments are due by 31 July 2013.  If you want to submit comments please use either of the comment templates Comments template – DOC (32kb) or  Comments template – PDF (56kb).  They ask that the comments are sent to EC-IMDRF2013-SECRETARIAT@ec.europa.eu.

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.

The first of the series of two guidance documents we will look at is the draft guidance on Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers 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:

Functions                                         Audits On-site             Audit/Decision Off-site

Conduct assessment application review       n/a                             Program administrator
to determine audit team competence
required, select the audit team members,
and determine audit duration

Assessment of quality management            Lead Auditor/Auditor    n/a
system

Assessment of product related                    Technical Expert         n/a
technologies

Assessment of Technical Files                   Technical Expert         n/a

Assessment of Regulations                        Lead Auditor/Auditor/   Final Reviewer/
                                                                Technical Expert         Technical Expert

Comments are due by 14 June 2013.  If you want to submit comments please use either of the comment templates Comments template – PDF (31kb) or  Comments template – DOC (54kb).  They ask that the comments are sent to the Medical Device Single Audit Program (MDSAP) Working Group Chair, Ms. Kim Trautman and with a copy to the IMDRF Secretariat.

The second in this series of draft guidance documents is titled Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers.  It was issued on 31 January 2013 with comments due by 14 June 2013. The draft guidance states “The purpose of this document is to specify competency requirements that shall be demonstrated and maintained by recognized Auditing Organization for personnel involved in medical device 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:

• Defining knowledge, skills, and abilities
• Criteria for various degrees of competency based on roles in audits and decision making functions
• Assisting in evaluation and development
• Providing a basis for identifying training needs

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

• Essential Principles of Safety & Performance of Medical Devices GHTF/SG1/N68:2012 supersedes GHTF/SG1/N41:2005
• Principles of Conformity Assessment for Medical Devices GHTF/SG1/N78:2012 supersedes GHTF/SG1/N40:2006
• Principles of Medical Devices Classification GHTF/SG1/N77:2012 supersedes GHTF/SG1/N15:2006
• Quality Management System – Medical Devices – Nonconformity Grading System for Regulatory Purposes & Information Exchange GHTF/SG3/N19:2012
• Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices GHTF/SG5/N8:2012
• Clinical Evidence for IVD Medical Devices – Scientific Validity Determination & Performance GHTF/SG5/N7:2012
• Clinical Evidence for IVD Medical Devices – Key Definitions & Concepts GHTF/SG5/N6:2012

In the Eucomed 18 Nov 2011 newsletter article they say “In March 2011, the regulatory authorities of the … GHTF took the decision to disband the GHTF … to be replaced by a ‘regulator-led harmonisation and collaboration group.’ … regulatory authorities felt that it was time to change the way the GHTF was operating so as to accelerate international medical device regulatory harmonisation.

For more details see the Eucomed newsletter article.