CE marking approval for medical devices in Europe


Gain market access in Europe with CE mark approval

CE marking certification medical devices BSIAs a Notified Body under the Medical Device Directives, BSI has the technical expertise and experience to provide CE marking services.CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU.

 




How do I obtain CE marking?

CE marking is the manufacturer's declaration that the medical device meets the appropriate regulatory requirements. 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 processess allow you to build  reliability and confidence into your CE marking project planning.

 

CE-Excellence: BSI technical documentation review services

CE-Excellence: technical documentation reviewsBSI 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.

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.

We can provide the following CE Marking services:

CE-Standard

CE-StandardThe 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.