Woundcare Medical Devices

Woundcare Medical Devices 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.

The diversity of intended uses and technologies means that an expert CE marking Notified Body such as BSI is essential in ensuring that you meet the necessary regulations and getting your devices to market quickly.

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.

Providing guidance for high risk woundcare devices

BSI is designated by the MHRA to certify woundcare devices utilizing tissue of animal origin, including TSE risk species subject to Commission Regulation (EU) 722/2012. We have a proven track record of successful consultations with many competent authorities and the European Medicines Agency (EMA).

We can provide guidance on woundcare combination products that incorporate medicinal components (ranging from known medicinal substances such as silver and iodine to more complex and borderline medicinal substances) that fall within MDD and Medicinal Products legislation.

Why choose BSI for your product compliance to the Medical Device Directives?

Our core competencies in ISO 13485 and CE Marking are perfectly matched to certify the complete range of woundcare products. Our woundcare team have a wealth of experience gained from both the device and pharmaceutical industries, to understand the complete range of woundcare technologies.