CE marking

CE marking

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CE Marking for medical devices
CE Marking for medical devices
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European market access

Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch.  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.

BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.


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Clinical Masterclass Series

Our webinar series is back!

Join us for part 2 of our Clinical Masterclass Series in 2023 and listen to our experts discuss various aspects of the MDR. From preparing a Clinical Evaluation Plan, to supporting you with preparing a Clinical Evaluation Report, advice on PMCF and SSCP and much more.




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Our global expertise

Download our services brochure to learn about the full range of certification services and support that we can provide for all medical devices.

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CE marking guide

This guide to our certification process will take you from your application to BSI through to a CE mark certificate being issued to your company.