EU Technical File Compilation to Obtain CE Marking Approval
The components of a CE Mark Technical File include:
- Description of the product family and justification for why each product 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.
As part of our CE Technical File or Design Dossier construction services, we will:
- Compile the EU Technical 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.
Please contact us to learn more about our Technical File preparation services.