MDCG issued guidance on designation,reassesment notification of conformity assessment bodies & notified bodies.
This will support the designating authorities responsible for assessing applications for medical devices and invitro diagnostic bodies. The intention is to bring consistency and to align the working practices of the different designating authorities. The first section of the guidance addresses the steps leading up to the inclusion of a notified body in the NANDO database, together with pre- evaluation and off-site activities, onsite assessment activities, post-onsite assessment activities and the decision on the designation.
Designation assessments:
Conformity Assessment bodies CABs applying for designation should know that the time needed for the assessment of the application, execution of the on-site assessment, assessment of the subsequent correction and verification activities, designation, and notification. The overall timing of the process depends upon the activities carried out by the CAB and relevant designating authority within the process itself.
The second section of the notification covers the objection period and the validity of the designation. MDCG also describes the reassessment process.MDR and IVDR require notified bodies to be reassessed three years after the original notification and every fourth year thereafter. The reassessment will bring the relevant changes to the notified body’s quality management system. After completing the process, the designating authority will update the notification in NANDO. This notification will be done by using a specific electronic notification tool within the commission of NANDO information system.
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