Writing and Updating Medical Device Technical File
A Medical device technical file is a compilation of the documentation required to demonstrate compliance to the relevant regulation. The file contains details of the design and intended use, as well as evidence of the safety and effectiveness of the device. The technical file must be kept up-to-date throughout the life-cycle of the device and must be made available on request of the competent authority. 5ai Consultancy specialises in the regulatory requirements for the EU and UK markets and have assisted clients in producing technical files to the necessary regulation.
According to Article 10 of the MDR ‘technical documentation shall be such as to allow the conformity of the device with the requirements of this regulation to be assessed’. The preparation of technical documentation, required for all classes of medical devices, is the manufacturer’s responsibility, as is the provision of access to these documents upon request by the CA or NB. Since technical documentation is often extensive, sections of it may be stored in different locations, which are usually controlled by the manufacturer’s quality management system. Furthermore, technical documentation must be updated promptly and as necessary during the lifetime of the device, to ensure it accurately reflects the current status, specification and configuration of the device.
A clear structure throughout the technical documentation is helpful in ensuring that the reviewing body can clearly understand the contents. Therefore, it is important for the manufacturer to maintain traceability from the User Requirements Specification (URS), to the Functional Requirements Specification (FRS), risk analysis, clinical evaluation and the general requirements for safety and performance, to ensure consistency of the evidence documents and records throughout the technical documentation.
A URS can determine several FRSs. Each FRS may be involved in several hazards and associated risks. Each risk, identified through a risk analysis, may be linked to one or more questions to be treated by clinical evaluation and to one or more general requirements for safety and performance. Keeping traceability of all of this within the manufacturer’s technical documentation, whilst challenging, is essential for demonstrating to CAs/NBs continuous fulfilment of the GSPRs.
When compiling technical documentation, manufacturers should ensure they take into account the MDR annexes,3 which determine the extent and detail by which the CAs/NBs will review the technical documentation, as determined by the MDR provisions.