The International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), has released two new consultations regarding its much-anticipated medical device single audit program (MDSAP), a program meant to facilitate third-party auditing.
The development of the MDSAP program is being coordinated by Kimberly Trautman, associate director of international affairs at the US Food and Drug Administration. Trautman has previously explained that auditing standards for organizations will "complement" the ISO 13485 standard, which deals with the quality regulations medical device manufacturers must follow.
"IMDRF seeks modifications to achieve a harmonized standard amongst its members," Trautman explained at a regulatory meeting in 2012 held by the Regulatory Affairs Professionals Society (RAPS). Other regulators, including Health Canada's Mike Ward, called the MDSAP the "future of regulation," noting that it will allow third parties to step in and help meet the needs of regulatory authorities.
In the meantime, IMDRF has been working through a number of thorny issues, among them how to ensure audit consistency among parties, which standards will complement the ISO 13485 standards, and how to best oversee auditing organizations.
In April 2013, IMDRF released two draft guidance documents on the program which respectively covered several core components of the program: Requirements for auditing organizations, and training requirements for auditors.
Now IMDRF is working to finalize two closely-related documents, releasing them for a 60-day consultation period.
The first, WG (PD1)/N6R3 - Assessor Competency and Training Requirements for Regulatory Authorities undertaking Assessments of Auditing Organizations, is meant to "specify competency requirements that shall be demonstrated and maintained by Regulatory Authorities for personnel involved in the assessment of Auditing Organizations (AOs)."
One of the most important responsibilities described in the document is the one given to regulatory authorities, which are instructed to "collect and maintain evidence" that the AOs and their personnel are meeting the requirements set forth in the remainder of the document. Those responsibilities fall into four different subsets, IMDRF wrote:
- to initially qualify their staff, who are involved in assessments and recognition decisions to the requirements specified within this document, based on demonstrated competence
- to ensure that the competence of personnel involved in assessments and recognition decisions is maintained on a continuing basis
- to provide personnel with appropriate support and resources where needed
- to maintain records of these activities including a signed Code of Conduct for each person involved in the recognition process
Auditing staff will also need to meet a number of various requirements in order perform audits, such as disclosing conflicts of interest, meeting educational and technical prerequisites, and demonstrating foundational and functional competencies.
The document is largely similar to the version released in April 2013.
The MDSAP Program in Detail
However, the second document, Regulatory Assessment Program and Assessment Strategy Utilizing for the Recognition and Monitoring of Medical Device Auditing Organizations, is considerably more extensive than a similar document released for consultation in April 2013.
The 112-page document explains nearly all aspects of the MDSAP program, including the assessment process itself, the controls required of AOs, the roles various team members will play in the auditing process, and potential outcomes of the assessment process.
Editor's note: While I ordinarily attempt to summarize documents for easier consumption, this one is so expansive and all-encompassing as to make that nearly impossible.
The consultation on the document ends on 30 August 2013.
Open IMDRF Consultations
2013 RAPS Session on the MDSAP Program