IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies
Posted 08 August 2019 | By
The International Medical Device Regulators Forum (IMDRF) opened a consultation on a draft document that sets forth requirements for regulatory authorities’ recognition of conformity assessment bodies (CABs).
The draft document proposes general and specific requirements as well as structural, resource, procedural, management system and information requirements for a regulatory authorities’ recognition of CABs for medical devices. It also outlines a process for authorities to revoke recognition.
General requirements discuss legal and contractual matters. “A legal entity is ineligible to be a medical device CAB if the entity has been found guilty of an offense against national laws or regulations related to medical devices, or relating to any fraudulent or dishonest practices.”
Requirements throughout draft document are based on the international standard on certification bodies’ process and services, known as ISO/IEC 17065:201ISO/IEC 17065:2012.
Exceptions are those that do not apply to premarket review conformity assessment and the specific requirements are in addition to those in ISO/IEC 17065:2012. The first set of specific requirements in the draft document addresses management of impartiality, liability and financing, confidentiality and publicly available information in accordance with 17065:2012.
As part of the process requirements, the draft document identifies elements of information that CABs should make sure are included in premarket applications under review. These include evidence in support of the product’s qualification as a medical device, risk classification and the conformity assessment procedures the manufacturer applied. CABs should also ensure that the application contains enough supporting evidence on conformity with IMDRF essential principles of safety and performance. The final document on essential principles was posted
IMDRF explains that the draft document is intended to complement its document on competence, training and conduct requirements for regulatory reviewers, which was finalized in 2016. Both documents were developed by the Good Regulatory Review Practices (GRRP) working group (WG), which is chaired by the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The GRRP WG plans to use the collection of final documents to create a program, tentatively dubbed the Medical Device Single Review Program, with the CDRH director leading efforts
for regulators to rely in whole or in part on each other’s decisions.
The consultation on the new draft document is set to close on 3 October.
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews