CE marking

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, and 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.

MDR and IVDR Regulations

Learn more on European Regulations by visiting our dedicated webpages.

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

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

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.

BSI provides experienced and efficient routes to global markets. Our expertise reaches all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We understand the challenges of achieving market access efficiently and safely, meeting commercial goals and regulatory requirements.

We developed our services to support manufacturers seeking timely and effective market access. Our services combine efficiency with the integrity, independence, and thoroughness you expect from BSI.

Technical Documentation Review Services deliver the efficiency you need to be competitive in the market and maintain trust:

Allows you to work closely with your assigned BSI Technical Specialist on your product certification. These reviews are conducted remotely between you and the Expert via phone and email, as required.

Allows you to schedule your Technical Documentation review with a dedicated BSI Product Expert. The review is conducted remotely and scheduled to allow you to engage with your dedicated BSI Product Expert and provide responses to their questions. This ensures predictability in review planning and improves the process efficiency.

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.