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, […]
Clinical Performance Evaluation of IVDs
Wien, 01.08.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) medical devices In vitro diagnostic (IVD) devices play a critical role whether to help diagnose diseases or conditions, monitor health status, or guide treatment decisions. For these reasons, a new Amending Regulation [EU 2024/1860] was published in July 2024 to extend the IVDR transition timelines while […]
Clinical evidence: essential for both investors and regulators
Wien, 09.07.2024 – Text: Catarina Carrão Medical technology start-ups: popular demand The need for innovative healthcare solutions is high, as such medical technology start-ups are increasingly popular. Whether developing new technologies, devices, and/or software that has the ability to improve patient outcomes and reduce healthcare costs, the incentive is there to identify a niche and develop something new. However, […]
Orphan medical devices: balancing the needs for clinical evidence
Wien, 02.07.2024 – Text: Catarina Carrão Rare diseases in the EU In the European Union (EU), 27 to 36 million people live with one of the estimated 6,000 to 8,000 rare diseases, which can affect anywhere from a few patients to as many as 245,000.1 Approximately 80% of these diseases are genetic, with 70% beginning […]
Is the Clinical Trials Enterprise broken and how can we fix it?
A report of the inaugural JAMA Summit Wien, 17.06.2024 – Text: Catarina Carrão The inaugural Journal of the American Medical Association (JAMA) Summit 1 was held last October and focused on clinical trials, the basis of evidence-based medicine. It was meant to address the provocative questions: Is the Clinical Trials Enterprise Broken? And How Can It Be Fixed? As such, an international group of invited clinical researchers, funders, regulators, policymakers, […]
International Clinical Trials Day: Data Centric Clinical Research
Wien, 20.05.2024 – Text: Catarina Carrão International Clinical Trials Day In May 2005, the European Clinical Research Infrastructures Network (ECRIN) begun celebrating the International Clinical Trials Day. This celebration yearly brings together patients, health policy actors, health authorities, clinical researchers, health professionals and citizens from across Europe and beyond to discuss issues related to multinational […]
Implementing the EU Health Technology Assessment Regulation (EU HTAR)
Wien, 24.04.2024 – Text: Catarina Carrão The development of health technologies is a key driver of economic growth and innovation in the European Union (EU), since health technologies constitute an innovative sector of the economy and form part of an overall market for healthcare expenditure that accounts for 10 % of the EU gross domestic […]
