CE marking

To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in European countries.

CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type.

As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

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