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. The benefit of CE marking is that it is a legal requirement to trade your device in the European market.
The CE Mark is a conformity mark which all medical devices must have before they can be marketed. It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact.
What is CE Mark Technical File or Design Dossier Compilation and Review?
Compiling your technical file or design dossier is a critical step in Europe’s CE Marking 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.
CE Marking Technical File
The technical file is a comprehensive collection of information and data that details everything about your medical device. If you manufacture a Class I device, a less complex CE Marking 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).
CE Marking technical file or dossier incorporates definite data about the design, function, composition, use, claims, and clinical evaluation of your medical device.
The CE Marking Process
An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. We Operon Strategist help you in the process of making a defined and comprehensive technical file with all product details required for CE marking. We also provide assistance in your process of making technical file and review it at every step for compliance with CE Marking.
We have the technical expertise and experience to provide CE marking services. Our team supports clients in meeting “European submission” standards that declares the product offered is in compliance with the Essential Requirements of relevant European safety, health and Environmental protecting regulation.
We are the leading Medical Device CE Marking Certification Consultant service provider for medical device disposable implant manufacturers, medical disposable syringe manufacturers, surgical instrument manufacturers, orthopaedic implant & instruments manufacturers, laboratory equipment manufacturers, sterilization equipment and accessories manufacturers, medical imaging systems manufacturers.