Conformity Assessment Procedure

As in the case of other European Directives on Medical Devices, a manufacturer can choose between different conformity assessment procedures, dependent upon the Classification of the respective device. The conformity assessment procedures described in Article 9 of the IvD Guideline include e.g. the Quality Management System in accordance with DIN EN ISO 9001/2 in conjunction with EN 46001/2, EC sample examinations, batch assessments or product design examinations.

A Notified Body must be appointed for devices falling under Annex II as well as for devices for self-testing. Some requirements however have to be met by all devices if they are to comply with the IvD Directive.

In vitro diagnostic medical devices which are neither allocated to Annex II List A or List B nor are devices for Self-testing or for performance evaluation studies need only comply with the Essential Requirements (Annex I of the IvD Directive). The graphics in our download-area give an overview of the different procedures for conformity assessment: