IMDRF publishes guidance on Conformity Assessment Body Assessment Process

The International Medical Device Regulators Forum (IMDRF) has published guidance document WG/N66FINAL:2021, titled ‘Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews’.

The document explains the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognizing Regulatory Authority’s assessment of a CAB; and to document the decision process for recognizing a CAB or cessation of recognition. To prevent confusion between marketing review activities performed by a CAB and the activities performed by medical device Regulatory Authority Assessors for CAB recognition and surveillance, in this document, the latter are designated as “assessments.”

Copies of the document can be obtained from here.