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 In another post I will follow-up on one other draft guidance document which is on the Regulated product submission (RPS) Table of contents.
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WARNING; It is critical to be aware that each comment template is specific to a specific draft guidance document and if you don’t use the proper one your comments could be skipped over or not aligned with the proper guidance document and you would then not have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 .
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