Regulatory Services

CE Certification

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, offering a range of product review services that provide efficient pathways to bring your product to market

CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union. 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. Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch.

To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product.

This dictates the required activities to demonstrate conformity. We will review the route you chose to confirm its suitability.

We will work with you to execute the most efficient review process for the selected route. Our trusted review processes allow you to build reliability and confidence into your CE Certification project planning.

Note: Our services do not guarantee an EU certificate will be issued nor that it will be issued within a certain number of working days but they are based on completing the review process with either a positive or negative recommendation. CE Dedicated is not available for devices utilizing animal tissue derivatives, human tissue derivatives or medicinal substances.

Regulatory Services

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