CE Mark / CE Marking Technical File Preparation Services
Emergo Group specializes in helping medical device and IVD companies prepare the necessary documentation to achieve CE Marking for their products. Perhaps most important component is the Technical File.
The Technical File lives up to its name because once completed, it will indeed be a "file" full of information. It is much more than a simple document and a critical key to compliance with the Directives.
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 where the device is used, what it is used with and who uses it
- An account of how the device(s) functions and what it actually does
- 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 the applicable Directives
- Declaration of Conformity that states manufacturers' 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
- References to Standards and Guidelines
- Testing results and clinical trials (if needed)
- Risk analysis
- Instructions for Use and Labeling
As you can see, the Technical File is a comprehensive collection of documents that details everything about your product(s). Understanding how to assemble this information and present the information properly is key. If you manufacture a Class 1 device, a less complex Technical File may be required. But in the case of Class 2a, 2b and Class 3 devices, a more complex Technical File must be prepared.
Technical File construction is subject to review by Notified Bodies if the device is Class 2a or higher. 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.
We have compiled and reviewed Tech Files and Dossiers for hundreds of medical device and IVD companies and can assist you with the preparation and compilation of your Technical File.
As part of our Technical File construction services, we will:
- Help you determine exactly which materials need to be assembled
- Completely review all existing documentation in support of meeting the applicable requirements of the Directive(s)
- Provide a base template which forms the "backbone" of your Technical File
- Determine applicable standards
- Facility risk assessment and implementation of the risk management process
Our Tech File preparation services are handled on a fixed price basis and include unlimited phone support during the duration of your project.
If you would like to learn more about Emergo Group's Technical File preparation services, please contact us.
