You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information, we mean technical documentation. All those documents you have to have it in one place, organized, before providing the final EU Declaration of Conformity.
A soon as you put together and sign the Declaration of Conformity, you are taking responsibility for the compliance of the medical device. It’s expected from you that you will be able to provide all the necessary technical documentation to get the CE mark.
Purpose of Technical File
The Technical File for your medical device basically has one goal. They supposed to ensure that your product's (medical device) evaluation is compliant with specified requirements. Those requirements must include suitable analysis and assessment of the risk(s). It needs to specify the appropriate requirements and cover, as far as relevant for the assessment, the design, production and operation of the product.
The directive clauses
The directives contain clauses which give some general details of the kind of information which will be required in the Technical File, but this is couched in the most general of terms. As a general guide, the following items should be included:
1. Device description
- Device description including any variations
- Photographs of the device
- Photographs of device usage
- Brochures, advertising, catalogs (if available)
2. Device specifications
- List of applicable standards
- Parts list - list of components
- Assembly and/or manufacturing drawings
- Specifications of materials used
- In case of a drug-device combination: a statement about the substance(s) used (if applicable results of the consultation- procedure)
- Manufacturing specification
- Sterilization specification
- Packaging specification
- QA specification
- Labeling, accompanying documents, package insert
- Description Of the creation of a Lot or Charge No.
- Instructions for use
- Intended / clinical use
- Indications and contra-indications
- Operating instructions / instructions for use
- Warnings / precautions
- Service Manual
- OEM contracts or supplier certificates
3. Device verification
- Testing data and reports, functionality studies, wet lab or benchtop testing
- Materials certificates/reports on stability, biological tests, cleanroom-surveillance
- EMC testing and certificates
- Compatibility studies
- Risk management- documentation
- Clinical data
4. Device validation
- Validation of the packaging/aging studies
- Process validation
- Software validation
Your Technical file will be able to see only the authorities that are given the power to enforce the directives. It doesn’t need to be available or given to customers. From the date, your medical device is last produced, the file must be available at least 10 years.
The file doesn’t have to be located in the European Community, but it must be made available to either the manufacturer’s authorized representative or the importer of the device as appropriate upon demand.