CE Mark is a worldwide-recognized certification mark for Health, Safety and Environment protection standards, enabling the sale of medical products in the EEA (European Economic Area).
CE Mark is a declaration by manufacturers that the products they are sell within the EEA are meeting the requirements of EC Directives.
In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device Directives.
CE certification is a legal requirement to sell your product or device in the European market.
All medical devices must have it before they can be marketed.
Compiling your technical file or design dossier is a critical step in Europe’s CE certification process and a requirement for compliance with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
The technical file is a comprehensive collection of information and data that details everything about your medical device. If you manufacture Class I devices, a less complex CE Mark Technical File may be required.
In the case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared.
EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier).
An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry.
We will help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.
We will also aid in your process of reviewing your technical file for compliance with CE Mark.
Our team supports clients in meeting CE Mark standards, declaring that the product offered is following the Essential Requirements of relevant European safety, health and environmental protecting regulation.
We specialize in CE certification for: