CE Marking for medical devices

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 route selected. Our trusted review processes allow you to build reliability and confidence into your CE marking project planning. 

BSI The Netherlands is a leading EU Notified Body; we review technical documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your technical documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers technical documentation review through our CE-Excellence services; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.

BSI has a strong commitment to providing the most experienced and efficient routes to global markets. That is why we offer you our trusted technical documentation review service, CE-Excellence. We understand the challenges of achieving market access efficiently and safely, meeting commercial goals and regulatory requirements. Our services have been developed to support manufacturers seeking timely market access without compromise. They combine efficiency with the integrity, independence, predictability and thoroughness that you have come to expect from BSI.

We can provide the following CE marking services:

The BSI CE-Standard review service allows you to work closely with your assigned BSI Product Expert on your product certification. These reviews are conducted remotely, with communication between you and your BSI Product Expert via phone and email, as required.

The BSI CE-Dedicated review service allows you to schedule your technical documentation review with a dedicated BSI Product Expert. The review is conducted remotely via teleconferencing, allowing you to engage with your dedicated BSI Product Expert and provide immediate responses to their questions. This allows predictability in planning for the review, and can improve the efficiency of the review process.

The CE-Onsite review service is conducted at your premises; a BSI Product Expert visits the facility for a period of time. CE-Onsite reviews allow for dynamic communications and opportunities for immediate responses to questions raised by the reviewer. Planning a CE-Onsite review in advance provides you with more predictability and the reassurance of knowing when your BSI Product Expert will be at your premises.

Note: Our services do not guarantee a CE Marking certificate will be issued within a certain amount of working days, but are based on completing the review process with either a positive or negative recommendation. CE-Dedicated and CE-Onsite is not available for devices utilising animal tissue, blood derivatives or medicinal substances.