European market access with a trusted CE Marking Notified Body

Accessing the European market brings challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure patient and user safety, as well as the performance of the device.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

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