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.
Our clients enjoy working with us because we understand the challenges medical device manufacturers face in getting compliant products on the market quickly. We are continually developing speed to market programmes to meet the demands of the medical device industry. The CE-90 is our standard Design Dossier service in which most reviews are completed within 90 working days from submission. We give you more predictability for better results.
Why choose BSI for your CE marking approval?
Expansion into global markets like Europe represents a profitable future for medical device manufacturers, but this transition also requires an in-depth understanding of complicated regulatory demands and unique market challenges. With the goal of bringing your product to market in the most efficient manner possible, we can help you overcome every hurdle along the way. Our wealth of expertise across the medical device space allows you to:
- Understand the regulations of three different council directives (AIMDD, MDD and IVDD) as well as the six amending commission directives, and other additional directives
- Move past unforeseen administrative setbacks without delaying market approval
- Define unclear requirements on the quantity and quality of clinical data required
- Resolve the unclear regulatory status of a (borderline) product
- Prepare for and adjust to any new and/or revised legislation that will go into effect during your review