Aug 13, 2019

The International Medical Device Regulators Forum (IMDRF) has published recommendations to establish more specific criteria whereby market regulators recognize conformity assessment bodies (CABs) for conducting premarket reviews of devices and IVDs.

The recent IMDRF draft guidelines are part of the organization’s broader efforts to develop a “common set of requirements to be utilized by the Regulatory Authorities for the recognition and monitoring of entities that perform regulatory reviews and other related functions,” according to the document. IMDRF plans additional guidance in relation to CAB recognition and related premarket review issues in the future.

IMDRF is accepting comments on the proposed CAB recognition requirements through October 3, 2019.

CAB premarket review process recommendations

In an effort to establish a more uniform process for CAB premarket review of device and IVD submissions across multiple markets, the new IMDRF document includes specific premarket application review and certification decision processes CABs should implement and conduct in order to achieve and maintain recognition from regulators.  

Additional proposed requirements for CAB recognition

The IMDRF proposed approach would keep the ISO/IEC 17065:2012 standard (Conformity assessment – Requirements for bodies certifying products, processes and services) as a generic baseline for CAB recognition requirements, supplemented with more specific requirements in the new document.

IMDRF requirements more targeted at device CABs are broken down into several categories, such as:

  • Legal and Contractual Matters, including a rule that no legal entity may act as a medical device CAB if it has ever been found guilty of violating any national device-related laws or regulations;
  • Exceptions to ISO/IEC 17065:2012 in instances where CABs must disclose to market regulators information pertaining to their agreements with manufacturers;
  • Management of impartiality, including requirements that CABs are independent of device manufacturers as well as other economic operators (in-country representatives and distributors/importers), and that CAB managers and personnel are not involved with or consulting manufacturer clients
  • Liability and financing, requiring CABs to purchase and maintain professional liability insurance coverage;
  • Confidentiality requirements to ensure secure handling of confidential data by CABs;
  • Publicly available information identified in ISO/IEC 17065:2012 must be available in all markets where a CAB operates, and CABs must also make publicly available their regulatory review and impartiality processes and policies.

CAB structural and resource requirements

In addition, the IMDRF document covers requirements for how CABs should organize their management structures and staffing. These requirements include keeping staff up to date on current medical device and IVD regulations, technologies and best practices; establishing codes of conduct; and adhering to IMDRF recommendations for regulatory reviewer competence and training.

Learn more about conformity assessments for medical devices and IVDs at Emergo by UL:

  • European Medical Devices Regulation (MDR) preparation and support
  • Whitepaper: Conformity assessment routes under the European MDR