IMDRF Issues Draft Criteria for Medical Device Auditing Organizations

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force, has proposed draft criteria for use by medical device market regulators to recognize qualified auditing organizations.

The draft proposal targets auditing processes conducted as part of conformity assessments as well as of post-market surveillance procedures; IMDRF members aim to establish a common list of criteria regulators can use to recognize or designate entities performing auditing services that cover medical device manufacturers. If adopted, the criteria could drive greater uniformity and efficiency in medical device quality system audits across global medical device markets.

Recognition criteria proposed by the IMDRF include normative ISO requirements as well as IEC document ISO/IEC 17021:2011.

Proposed requirements for auditing organizations would include:

  • Legal establishment according to appropriate national laws
  • In cases where the auditing organization is part of a larger firm, activities of that larger firm as well as its organizational structure must be documented
  • Auditing organization’s ownership or interests in other legal entities must be defined and documented
  • Auditing organization must report to appropriate regulators any fraudulent or counterfeiting activities as well as any safety or performance issues discovered during the auditing process
  • Any company that has been convicted of violations against pertinent national laws or regulations involving medical devices is ineligible for qualification as an auditing organization


Interested stakeholders may provide comment on the IMDRF proposals through December 2012. The IMDRF management committee plans to add additional requirements to the proposal at its next meeting in March 2013.