The requirements for the technical documentation are laid down in the various Annexes of the medical device Directives,as appropriate for the conformity assessment procedure and the products concerned.As a general rule,the documentation should cover the design,manufacture and intended operation of the product.
A quality manual and program files of company
B Enterprise Profile,the name and the contact information of the European Agent
C CE declaration of conformity
1 Product name,classification and the brief description of reference standard clause.
2 Products overview(including type and intended use)
A) the history products
B) the technical performance parameters
C) the accessories,fitting pieces and samples of product
D) the graphical representation and samples of product
E) the raw materials and suppliers of products
3 Regulatory standards applied or other standards
4 Risk analysis and prevention measures
5 Production quality control
A) product information and control documents(including production flow chart)
B) product decription of sterilization method and confirmation
C) sterilization verification
D) product quality control measures
E) description product stability and the validity
6 packing and marking
A) packaging materials introduction
B) label
C) instruction of use
7 Technology assessment
A) product inspection reports and related documents
B) technology overview and authoritative view
8 Potential risk assessment
A) potential risk test report and related documents
B) outline of the potential risk and authoritative view
9 Clinical evaluation
A) clinical test report and related product literature
B) clinical overview of use and authoritative view