Product category: Certification and testing of medical devices, quality assurance
CE marking approval for medical devices in Europe
Gain market access in Europe with CE mark approval CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the European Union.
As a Notified Body under the Medical Device Directives, BSI has the technical expertise and experience to provide CE marking services.
Conformity assessment service for medical device CE marking
The CE marking process can be a challenge for both smaller companies and global manufacturers. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives in the EU. In order to obtain CE certification, you must 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 timely processess allow you to build reliability and confidence into your CE marking project planning. And to add further efficiencies to the process, we may be able to offer dedicated review days, or onsite assessments.
As a Notified Body under the Medical Devices Directives, we have one of the broadest scopes of any Notified Body.
The Medical Devices Directive (MDD) - all products The Active Implantable Medical Devices Directive (AIMDD) - all products The In Vitro Diagnostics Directive (IVDD) This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is now a legal requirement, BSI has the technical expertise to provide appropriate conformity assessment services.
BSI is the business standards company that helps organizations all over the world make excellence a habit. For more than a century we have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organizations improve, our clients range from high profile brands to small, local companies in 150 countries worldwide.
Find out more about BSI and visit our website on www.bsigroup.com.