Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Clinical Evidence Under the New Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices

Dominik Sebastian (Abschlußjahr: 2017)

Summary
Language: English
The regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) was published in the Official Journal on 5 May 2017. With this, a process that started over 10 years ago has reached an end.
The IVDR brings changes to any aspect of the IVD lifecycle; some are more pronounced and some not so much.
An aspect that has seen substantial change is "clinical evidence". This is a new concept of the IVDR, which is build upon the performance evaluation from Directive 98/79/EC (the IVD directive, IVDD). In the IVDR, the analytical and clinical performance data, which was already required under the IVDD, has to be complemented with data on the scientific validity of a device. The process of performance evaluation means the generation of the data on scientific validity, analytical and clinical performance. The performance evaluation data and a critical assessment of the data constitute the clinical evidence for the device and must demonstrate that the device is safe and achieves the intended clinical benefit.
The clinical evidence must be kept up to date throughout the lifecycle, which shall be achieved by post-market performance follow-up (PMPF). This is yet another new term from the IVDR for a process that is related to the vigilance procedure from the IVDD but has a much broader scope and that is proactive rather than reactive.
The present thesis first compares the texts of the IVDD and the IVDR with regard to these aspects. This is followed by a step-by-step guide on the generation of clinical evidence under the IVDR. Then it is discussed where manufacturers can rely on their existing processes in the implementation of the IVDR requirements and where challenges might be waiting. Finally a brief outlook on upcoming steps is provided.
Pages: 45
Annexes: none