Regulatory Services

CE Marking

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.

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.

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 marking 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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Why choose BSI for your CE marking?

A full scope Notified Body.

General Medical Devices
Active Implantable Medical Devices
In-vitro Diagnostic Medical Devices

Benefits of CE marking with BSI

BSI The Netherlands (2797) is a full-scope Notified Body designated for all three types of devices under MDR and IVDR

As a manufacturer, this simplifies the certification of your medical devices and saves you from managing your product portfolio among different Notified Bodies.

Our team has a unique set of expertise that allows to provide a rigorous review of your Technical Documentation. You will be assigned a dedicated BSI Scheme Manager to work with throughout your product certification journey and will remain your point of contact thereafter.

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