When the Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR) became generally applicable, new requirements for the evaluation of the performance of in vitro diagnostics were implemented. We can support you in the analysis of your documents and determine which changes, if any, will be needed, regarding content as well as the formal structure, to achieve conformity with the IVDR.
The gap-analysis serves to identify and delineate potential shortcomings in the analytical and clinical performance evaluation of IVDs as well as in the presentation of the scientific validity of the method used. First and foremost, aspects of the content are analysed. This includes the choice of equivalent products and the available data regarding performance and safety (i.e. from the literature and own studies) followed by an appraisal of the provided information regarding the question whether it is sufficient to demonstrate validity of all claims and indications in compliance with the IVDR. Furthermore, the documents are investigated regarding potential formal deviations which may not conform with the IVDR. Special attention is paid to the comprehensive documentation of the literature search, the appraisal procedure of the literature, and the presentation of the criteria for equivalence and the state-of-the-art methods.