Technical File Preparation to Obtain CE Marking Approval
Emergo Group specializes in helping medical device and IVD companies prepare the necessary documentation to achieve CE Marking certification for their products. A required component is the Technical File (called a Design Dossier for Class III devices).
The components of a CE Mark Technical File include:
- Description of the product family and justification for why each products falls within the product family.
- Detailed account of the intended use of the device(s) including how the medical device(s) functions, what it does, where the device is used, what it is used with, and who uses it.
- Description of components, specifications, packaging and literature.
- The manufacturing process.
- Listing of accessories.
- Location of design responsibility and manufacturing facilities.
- Classification of the device and rationale for classification.
- The chosen route to compliance according to the applicable Directives.
- Declaration of Conformity that states the manufacturer's compliance with applicable Directive(s).
- Lifetime/shelf life of products and environmental limitations.
- Retention of QA, Competent Authority and Notified Body records.
- Vigilance reporting and Medical Device Reporting procedure.
- How and when to contact Competent Authorities.
- Name of, and contract with, your Authorized Representative in Europe.
- Subcontractor names and addresses, if applicable.
- Essential Requirements.
- Design input specifications.
- Application and references to Standards and Guidelines.
- Testing results and clinical evaluations.
- Risk analysis.
- Instructions for Use and Labeling.
A CE Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex Technical File may be required. In the case of Class IIa, IIb and Class III devices, a more complex Technical File or Design Dossier must be prepared.
Technical File construction is subject to review by a Notified Body if the device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). Once placed on the market, national Competent Authorities have the right to review Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry.
Emergo Group has compiled and reviewed Technical Files and Design Dossiers for hundreds of medical device and IVD companies.
As part of our CE Technical File or Design Dossier construction services, we will:
- Compile the Techincal File or Design Dossier.
- Help you determine exactly which materials need to be assembled.
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).
- Determine applicable standards.
- Facilitate Risk Assessment.
- Review labeling and Instructions for Use.
- Develop and implement risk management process.
- Assist in writing the clinical evaluation summary.
Our Technical File preparation services are handled on a fixed price basis.
Please contact us to learn more about our CE Technical File and Design Dossier preparation services.
