Regulation of medical devices in Europe and Africa

Abstract

Medical devise regulation worldwide is diverse. Regulation is evolving as a result of the necessity to enhance patient safety. In Europe, the medical device directives were reviewed leading to the development of the Medical Device Regulation (EU 2017/745) which will come into force in May 2021 because of the corona virus pandemic. Scandals such as those involving the silicone breast implants and metal to metal hip implants drove the need to institute changes in the regulation that had the patient's safety and well-being in mind. Many countries in Africa do not have medical device regulations in place or implemented varied regulatory practices. The regulatory authorities are constrained in terms of human resource and funding to effectively regulate medical devices. Given this background, the quality, safety and performance of medical devices placed on the African market is not guaranteed. Research on regulation of medical devices in Africa is particularly limited.