During the internal production control and inspection a manufacturer or his Authorised Representative ensures and throughout collection of appropriate technical documentation, declares conformity of medical devices with the requirements of the Technical regulations concerning medical devices. From the list of such documentation the Technical file should be identified, since it is the “passport” of a medical device.
Technical file – is the documentation, containing the conditions and requirements for the design, market circulation, handling, and utilization of manufactured products. Technical file shall be presented in the language, which was chosen by the manufacturer, distinctive of an arbitrary form but, however, shall contain a sufficient amount of information to be able to assess the conformity of the medical device with the provisions in the Technical Regulations.
Requirements for technical documentation are presented in a variety of Annexes of the TR, depending on the type of medical devices being assessed and the selected conformity assessment procedures. The technical documentation shall reflect the processes of design, production and subsequent use of the product. Moreover, information, which is contained in the documentation, depends on the type of product and on what is considered as necessary from a technical point of view to demonstrate compliance with the essential requirements of the TR.
When applying the relevant standards, technical documentation shall clearly indicate in what a way they are used to demonstrate compliance with the essential requirements specified by these standards.
The content of Technical Documentation will vary in each case based on the type of a product, risks during manufacturing, installation, operation and service maintenance, as well as the duration of the product presence on the market.
Therefore, there is no general manual on compiling the Technical Documentation. Our daily activities are based on international practice of developing of such documents, guided by European and national regulations.
Technical File shall contain the following essential elements:
- general description of the medical device, including any planned modifications, as well as the intended use;
- a description of the production process along with the description of the technologies used to provide the necessary parameters and to achieve an expected performance;
- design drawings, information about the envisaged manufacturing methods, as well as the diagrams of components, sub-assemblies, production chain, etc., as well as explanations necessary for its understanding;
- definitions of technical requirements and a decisions to be made by the manufacturer while medical device design and development to meet these requirements;
- information about standards applied in full or partly;
- the results of risk analysis at the manufacturing stages;
- specification of materials and manufacturing processes;
- in-process control methods;
- performance and compatibility provided by the manufacturer;
- description of sterilization methods, as well as the validation report (for sterile products);
- expiration date of the products;
- results of a clinical testing;
- labeling and User’s Manual (instruction for use).
In order to ensure legal protection of confidential information, which may be contained in the Technical File, at all the levels of processing by third parties during its compiling, conformity assessment, inspection and surveillance, the file is often divided into two parts:
- Part A (open part);
- Part B (confidential).
Thus it is possible in advance to secure by preventing disclosure of information that describes applied technologies, models, methods and drawings, revealing it to inspectors or auditors only on the basis of confidentiality agreement.
Cratia provides services in compiling, editing, filling in and translating of parts of Technical File. We have all the necessary experience in working with the international document formats and own-developed individual approach to the development and maintenance a manufacturer’s technical documentation. While developing the technical documentation, we always take into account the particular production and the specific requirements of national and European legislation.