Woundcare is a diverse field with a wide range of treatments, utilizing an array of technologies. This diversity is mirrored by the range of classifications that apply. Devices can span the entire spectrum of classification.What are woundcare medical devices and how are they classified?
Woundcare devices range from the simplest classification, Class I through to the highest classification, Class III depending on the technology and intended use. The regulatory route to compliance is also broad ranging from self certification by the manufacturer to detailed reviews and approvals involving a Notified Body such as BSI and a Competent Authority.
As a result of this diversity and the growing need to address the broad spectrum of woundcare devices, the need for an expert CE marking partner is essential.
