Friday, 10 November 2023 / Published in White Paper
FOREWORD BY MECOMED In the Middle East and Africa (MEA) region, the implementation of health technology assessment (HTA) is in its nascent stages. Among countries in the region, there are differing levels of understanding of how health technologies should be evaluated, while guidelines on the HTA of medical devices, including in-vitro diagnostics(IVDs), are largely absent.
Friday, 10 November 2023 / Published in White Paper
Abstract The healthcare landscape is undergoing a revolutionary transformation, thanks to the advent of the Digital Health Ecosystem. This interconnected landscape of multiple stakeholders is reshaping the way healthcare service providers approach healthcare delivery and patient care. This white paper explores the various components of the Digital Health Ecosystem, as seen from the Mecomed perspective,
Thursday, 14 September 2023 / Published in White Paper
Background: As of January 2, 2024, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will be transitioning from paper export documents for medical devices to electronic export documents, as per a recent letter communicated to the industry on July 10. The Documents to be issued electronically include: Certificate to
Mecomed Paper on UDI Recommendations
Friday, 19 May 2023 / Published in White Paper
We strongly encourage health authorities implementing (UDI) regulations to harmonize their UDI requirements in line with the (IMDRF) UDI guidance*. This will ensure global harmonization and facilitate compliance across the medical device and IVDs industry, when it comes to leveraging: an internationally accepted UDI coding system (e.g., GS1, HIBCC, or ICCBBA), IMDRF UDI labeling recommendations,
Wednesday, 10 May 2023 / Published in White Paper
On 6 January 2023, the European Commission proposed a Regulation to amend the transitional provisions of the Medical Devices Regulation (MDR – (EU) 2017/745) and the in-vitro Diagnostic Medical Devices Regulation (IVDR – (EU) 2017/746). On 16th February and March 7th respectively, the European Parliament and the Council of the European Union officially adopted the
Mecomed Whtepaper
Wednesday, 11 May 2022 / Published in White Paper
Health data & the MedTech industry The collection, sharing and use of health data is fundamental to advancing healthcare, research and innovation, ensuring the highest levels of safety and quality that also translate to improved health outcomes at lower total cost. As part of the development of new technologies and as part of their roll-out
Thursday, 22 April 2021 / Published in White Paper
Introduction In Vitro Diagnostics (IVD) provide vital information to aid clinical decisions from screening, diagnosis, treatment, prognosis, and monitoring. They are key to ensuring the right treatment is delivered to patients within critical timeframes. Healthcare decision-making is accelerating and professionals are expected to do more with timely information. Rapid delivery of accurate lab tests, with
Thursday, 22 April 2021 / Published in White Paper
Introduction 1.1 Health and Economy are Synergistic Population health and well-funded resilient healthcare systems are indispensable for economic prosperity. The unprecedented global public health crisis in 2020 served as a strong reminder of the health-impact on economies. Now more than ever, healthcare systems are under tremendous pressure to accommodate growing numbers of patients and achieve
Thursday, 25 February 2021 / Published in White Paper
Health is considered the cornerstone for economic prosperity, social, environmental and human development. However, health systems, payers and governments worldwide are under intense pressure. On one hand, healthcare costs are spiralling and growing faster than national economies, and on the other, despite increased spending, there are still high variations in patient outcomes and overall quality