CE Mark Is Not Enough: Medical Device Safety in African Healthcare Systems
- 1Biomedical Engineering Unit, Department of Physiology, Makerere University, Kampala, Uganda
- 2Department of Pharmacy, Makerere University, Kampala, Uganda
Abstract
Across African health systems, CE marking is often used as an important regulatory or procurement screening criterion for imported medical devices. Yet the CE symbol is not, by itself, a safety certificate issued by a regulator; it is a manufacturer’s declaration of compliance with applicable European Union requirements, supported by technical documentation and, depending on device classification, notified-body assessment. This commentary examines the risks that arise when a CE claim is accepted without verifying the supporting documentation, device identity and configuration, or post-market performance. Drawing on regulatory literature and published African evidence, it discusses documented equipment and device-management failures while noting that direct evidence attributing such failures to false or unsupported CE claims remains limited. It reviews emerging regulatory responses, including Uganda’s National Drug Authority framework, South Africa’s Health Products Regulatory Authority requirements, and continental initiatives. It argues that strengthening medical device safety in Africa does not require abandoning regulatory reliance, but does require verifiable documentation, risk-based oversight, stronger post-market surveillance and regulatory cooperation. CE marking should be treated as an important input into verification, not the end of the process.
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BibTeX
@article{matovu2026mark,
title = {{CE Mark Is Not Enough: Medical Device Safety in African Healthcare Systems}},
author = {Brian Matovu and Robert T Ssekitoleko and Success Kamuhanda and Kennedy Odokonyero},
journal = {Medical Devices (Auckland, N.Z.)},
year = {2026},
month = oct,
doi = {10.2147/mder.s649650},
url = {https://doi.org/10.2147/mder.s649650},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - CE Mark Is Not Enough: Medical Device Safety in African Healthcare Systems
AU - Brian Matovu
AU - Robert T Ssekitoleko
AU - Success Kamuhanda
AU - Kennedy Odokonyero
PY - 2026
DA - 2026/10/21
JO - Medical Devices (Auckland, N.Z.)
DO - 10.2147/mder.s649650
UR - https://doi.org/10.2147/mder.s649650
AB - Across African health systems, CE marking is often used as an important regulatory or procurement screening criterion for imported medical devices. Yet the CE symbol is not, by itself, a safety certificate issued by a regulator; it is a manufacturer’s declaration of compliance with applicable European Union requirements, supported by technical documentation and, depending on device classification, notified-body assessment. This commentary examines the risks that arise when a CE claim is accepted without verifying the supporting documentation, device identity and configuration, or post-market performance. Drawing on regulatory literature and published African evidence, it discusses documented equipment and device-management failures while noting that direct evidence attributing such failures to false or unsupported CE claims remains limited. It reviews emerging regulatory responses, including Uganda’s National Drug Authority framework, South Africa’s Health Products Regulatory Authority requirements, and continental initiatives. It argues that strengthening medical device safety in Africa does not require abandoning regulatory reliance, but does require verifiable documentation, risk-based oversight, stronger post-market surveillance and regulatory cooperation. CE marking should be treated as an important input into verification, not the end of the process.
SN - 1179-1470
ER -