Jan 3, 2014

The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.

The IMDRF has designated ISO/IEC 17021:2011 as the normative reference or baseline standard for market regulators overseeing medical device auditors active in their jurisdictions, but adds additional requirements more specifically addressing medical device industry issues. By establishing ISO/IEC 17021:2011 as a normative reference, IMDRF member regulators intend to promote a more consistent and relevant process for formally recognizing organizations that certify quality management system compliance.

Among the IMDRF’s recommended requirements:

  • Legal and contractual requirements involving regulators, auditing organizations and manufacturers
  • Tighter rules of impartiality for auditors and their medical device manufacturer clients
  • Liability insurance rules for auditors
  • Organizational and management structure requirements for auditors
  • Competency requirements for personnel involved in auditing medical device firms

For medical device manufacturers and their audit providers active in markets participating in the Medical Device Single Audit Program (MDSAP) pilot, these IMDRF recommendations provide a good idea of how US, Canadian, Brazilian and Australian regulators will coordinate their oversight of quality system auditing practices. Although regulators in the European Union and Japan are not participating in the MDSAP pilot (at least, not yet), it’s a safe bet that they will eventually sign on to the program. The sooner manufacturers and auditors familiarize themselves with the IMDRF recommendations, the better—not just for compliance purposes, but also to realize the benefits of more harmonized quality system inspection and auditing rules across multiple jurisdictions.

Stewart Eisenhart


  • Stewart Eisenhart