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MDR, IVDR and UKCA Resources
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Next steps

Whether you start your application, want to discuss your next steps or just need more information, please contact our team and we will be happy to support.

Contact Charlotte Hess

Contact

Charlotte Hess

Business Development Manager
Regulatory Services for IVD

+49-(0)174-3427572

Email

Frederic Becker

Business Development Manager
Regulatory Services for Medical Devices

+49-(0)175-9306687

Email

Why choose BSI as your notified body?

We are a global organization, trusted and recognized around the world. 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.

It is critical to work with a notified body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, promptly and robustly. At BSI, our technical specialists have extensive experience and can support you through the process of certifying your medical devices.

BSI Compliance Navigator

Navigate the MDR/IVDR transition easily

Over 300 harmonized standards are changing!

BSI's Compliance Navigator will include every one, before and after the change, and with alerts to keep you informed at every step of the development pipeline, your business doesn't miss a detail. 

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