Obtain CE Marking

European Union Technical File (Design Dossier) for CE Marking Approval

See all Benefits of INDEPENDENT regulatory representation and medical device registration services.

We help medical device and IVDs companies prepare the necessary documentation to achieve CE Marking certification for their products. A required component is the CE Technical File (called a Design Dossier for Class III devices).

A CE Technical File is a comprehensive collection of information and documents detailing everything about your medical device. Understanding how to assemble this information and present it properly is essential. If you manufacture a Class I device or self-certified IVD, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and Class III devices (and Annex II, List A; Annex II, List B; or self-testing IVD), a more complex CE Technical File or Design Dossier must be prepared.

The EU Technical File 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), or if Annex II, List A; Annex II, List B; or self-testing IVD. Once placed on the market, national Competent Authorities have the right to review EU 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. To learn how the Technical File fits into the CE Marking process, read the documentation explaining the European regulatory process.

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.

We compiled and reviewed CE Technical Files and Design Dossiers for hundreds of medical device and IVD companies. You can also read our in-depth article about the format and components of a Technical File

CE Technical File or Design Dossier compilation services comprises: 

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. Our European Technical File preparation services are handled on a fixed price basis. 

CE Certification – CE Mark Certification for Medical Devices

In order to commercialize medical and in vitro diagnostic devices in the European Union, manufacturers must obtain CE Marking certification and affix the CE marking as part of their device registration efforts.

CE Marking certification verifies to EU regulators that your device meets all requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. You must obtain CE Marking certification prior to marketing, distribution and sale of your product in any EU member state.

You are solely responsible as the medical device manufacturer for maintaining compliance with EU directives and securing CE Marking certification for your product, regardless of whether you outsource any or all components of your manufacturing operation.

Qualifying for CE certification and marketing your medical device in the EU requires the following steps:

1. Prepare a CE Marking Technical File or a Design Dossier for a Class III device that includes data proving compliance with the MDD, IVDD or AIMD.
2. Obtain your CE Marking certificate from an Accredited Notified Body.
3. Select and appoint a European Authorized Representative to act on your behalf within the EU.
4. Register your medical device with the appropriate Competent Authority, if necessary.

Completion of these requirements allows you to claim CE Marking certification for your device.

We have assisted hundreds of medical device manufactures with their CE Marking certification efforts. Services we provide to help you obtain CE certification include product classification; technical file and design dossier preparation; ISO 13485 quality system implementation and auditing; and ISO 14971 risk assessment and management needed for entering the European Union Market.

Please contact us for more information on the CE Mark certification process.

STED - Summary Technical Document Preparation 

A Summary TEchnical Document (STED) is a harmonized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to globally standardize regulatory submissions. 
The five GHTF members are actively using or evaluating STED as a pilot program: Australia, the European Union, Japan, Canada and the United States. Canada now requires the STED format for Class III and IV medical device license submissions. In Japan, the Japanese submissions are essentially required to be in STED with more detail. The information required for the preparation of a Summary Technical Document (STED) is most similar to the documentation required for a European Technical File. Other countries around the world have begun to accept the STED or ASEAN CSDT. We have expertise in preparing submissions in the STED format and we can fully assist in preparing or reviewing submissions for your medical devices for any of the markets mentioned above.

Please contact us for more information on preparing or reviewing a Summary Technical Document (STED) submission.