EU Technical File Compilation to Obtain CE Marking Approval
Bielderman, as specialized in European Regulatory Strategy, can help medical device and IVD companies to prepare the necessary documentation to achieve CE Marking certification for their products. A required component is the CE Technical File also called a Design Dossier for Class III devices.
European CE Mark medical device certification process
A CE Technical File is a comprehensive collection of information and documents that details everything about your medical device. It is essential to Understand how to assemble this information and present the information properly. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. A more complex CE Technical File or Design Dossier must be prepared, in the case of Class IIa, IIb and Class III devices.
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). The national competent authorities have the right to review EU Technical Files, once placed on the market, regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry.
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.
- Declaration of Conformity that states the manufacturer's compliance with applicable Directive(s).
- Location of design responsibility and manufacturing facilities.
- The chosen route to compliance according to the applicable Directives.
- Design input specifications.
- Classification of the device and rationale for classification.
- Essential Requirements.
- Lifetime/shelf life of products and environmental limitations.
- Retention of QA, Competent Authority and Notified Body records.
- Vigilance reporting and Medical Device Reporting procedure.
- Application and references to Standards and Guidelines.
- Testing results and clinical evaluations.
- How and when to contact Competent Authorities.
- Name of, and contract with, your Authorized Representative in Europe.
- Subcontractor names and addresses, if applicable.
- Risk analysis.
- Instructions for Use and Labeling.
Bielderman has compiled and reviewed CE Technical Files and Design Dossiers for hundreds of medical device and IVD companies.
We will, As part of our CE Technical File or Design Dossier construction services:
- Compile the EU Technical File or Design Dossier.
- Assist in writing the clinical evaluation summary
- 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).
- Develop and implement risk management process.
- Determine applicable standards.
- Facilitate Risk Assessment.
- Review labeling and Instructions for Use.
Our European Technical File preparation services is based on a fixed price.