Combined Clinical Studies
Wien, 10.12.2024 – Text: Catarina Carrão Combination products Combination products are progressively integrating cutting edge, novel technologies that hold great promise for advancing patient care. Such innovative drug, biological product, device combinations have the potential to make treatments safer, more effective, or more convenient to patients. For example, drug-eluting stents may reduce the need for repeated […]
Harmonised European Standards
Wien, 18.11.2024 – Text: Catarina Carrão The General Framework for harmonised European Standards (hES) Under the MDR 2017/745 and IVDR 2017/746 regulations, harmonized European standards (hES) play an important role. The legislation only sets out the basic requirements that products must meet to be sold in the European Union (EU). The technical details and specific product features needed to meet these […]
Clinical Performance Studies of IVDs
Wien, 11.10.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) devices: clinical performance studies Despite extended transition periods and multiple guidelines, IVDR remains difficult to interpret and bringing devices into compliance requires additional efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance studies with the device and its analytes. As […]
eConsent
Wien, 01.09.2024 – Text: Catarina Carrão Introduction eConsent refers to the process of obtaining informed consent from participants in clinical trials using electronic systems and processes. This method involves using electronic tools, such as tablets, computers, or smartphones, to present information about the trial and to collect signatures from participants. Misconceptions eConsent and remote consent are often confused, […]
