In previous weeks, Requalite team members made insightful presentations in two different sessions in the LabMed Forum hosted by Medica Dusseldorf. The LadMed Forum hosted several distinguished professionals working in the medical device industry and various significant presentations were made in the sessions. The speakers of the first session were Dr. Ayşe Begüm Tekinay and Anne Ziel. They made a presentation titled “MLF: Regulatory path for LDTs under IVDR.”
In vitro diagnostic medical devices are known as tests used on biological samples to determine the status of a person’s health. The In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force in 2017 and became applicable on 26 May 2022. The IVD Regulation is very critical as it seeks to ensure a high level of public health and patient safety.
The second session speakers of the LabMed Forum were the managing director Dr. Hakan İnan and Requalite team member Dr. Mustafa Köksal. They presented about the topic “MLF: How to act as a clinical study site as a laboratory – A case study of COVID-19 tests” A successful clinical investigation is supposed to assess the safety, clinical performance and effectiveness of a medical device for a particular indication or intended use and in this regard clinical investigations play a vital role for IVDR.
15.11.2022
