Assessment & Decision Process for the Recognition of a Conformity Assessment Body -IMDRF

International Medical Device Regulators Forum (IMDRF) published a final document describing the “Assessment and Decision Process for the Recognition of a Conformity Assessment Body (CAB) Conducting Medical Device Regulatory Reviews”.

This is one document in a collection of documents produced by the IMDRF intended to improve the efficiency and effectiveness of the review process for the marketing of medical devices.

The purpose of this document is to explain 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.

This document defines:

- the process and lifecycle for recognizing, maintaining, or ceasing recognition of a CAB;

- the process of managing, grading, and closure of assessment nonconformities issued to a CAB; and,

- the outcomes of an initial, surveillance, or re-recognition assessment of a CAB