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July/August 2023 | Volume 20 | No.7
This edition of Regulatory Rapporteur explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing impact of the EU Medical Devices Regulation (MDR) on clinical studies and data.
By Ash Ramzan
The regulatory landscape in African nations is evolving rapidly, and regulatory systems continue to be strengthened at regional and national levels. This article reports on progress being made, including the establishment of the African Medicines Agency, and the African Medicines Regulatory Harmonisation (AMRH) initiatives that have improved regulatory harmonisation in these nations.
By Ian Hudson, David Mukanga, Chimwenwe Chamdimba, andMargareth Ndoomonda-Signoda
The regulation of human tissue-based products around the globe is varied and complex. From the perspective of a competent authority inspector, this article explores human tissue regulation in countries including China, the US and Canada, and variations in inspection style.
By Simon Hoffman
The impact of clinical data requirements changes following implementation of the EU Medical Device Regulation and Clinical Evaluation Guidance
Implemented in May 2021, the EU Medical Device Regulation has changed the requirements relating to clinical evaluation and clinical data. This article discusses the new requirements and their impact on manufacturers and notified bodies.
By Andrew Jackson andVinetta Brew
The EU In Vitro Diagnostics Medical Devices Regulation (IVDR) was adopted in May 2022 and provides little guidance on requirements for in vitro diagnostic devices (IVDs) in clinical trial settings. This article discusses key considerations and challenges in initiating clinical studies under this regulation.
By Suzanne Jenkins, Sabina Patel, Roy Milner, Lena Jansson,
Maria Fernandez, Marta Thomson, Patrick Fivey and Joan Boren
A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA: is there a difference and does it matter?
In the second of a two-part series, this MSc dissertation provides an in-depth evaluation of EMA and FDA scientific advice procedures. It addresses the differences in SA between the two agencies, and determines whether these impacted the timings of meetings, the quality of advice obtained, and the overall development programme strategies.
By Hilary Gray
Regulations for hearing aids are broad, complex, and sometimes conflicting. This article provides guidance for hearing aid manufacturers wishing to place their devices on the EU market, including device classification, battery regulation, and general safety and performance requirements.
By Blathnaid Feldmen