This article deals with general requirement for technical documentation as defined in Medical Device Regulation (MDR) 2017/745. The MDR clearly defines requirements for documentation in Annex II and Annex III.
Technical documentation is a core part of the process of approval of medical devices. The MDR describes in more detail what information a manufacturer must document and emphasizes continuous updating of information during the product life cycle.
Requirements for documentation in Annex II
- Description of the device
The first section must contain the general characteristics of the product:
- name and address of the manufacturer,
- all trade names of the medical device with its unique device identifier UDI-DI, which gives us the “access key” to the information stored in a UDI database,
- rationale for the qualification of the product as a device and classification into a specific risk class, which should be justified according to Annex VIII,
- general description of the device, including variants and configurations available, intended accessories and incorporated raw materials,
- description of the principle of operations,
- description of the key functional elements/parts/components and technical specification
- identification of the intended users or patients and their medical conditions, which need to be diagnosed, treated or monitored,
- presentation of various indications, contraindications and possible warnings,
- reference to an older generation of a medicinal product or similar devices, if existing in the European Union or internal markets,
- explanation of any new characteristics of new intended purposes.
- Labeling
Manufacturers are responsible for ensuring accurate translation of e.g. labeling, instructions for use and product claims in marketing material. Accurate translation is especially important in the case of user instructions where the safety and claimed performance of the device may be compromised through inadequate translation.
- Design and manufacturing information about the device
The stages of product design and development are described. The manufacturing process and its validation with supporting complete information and specifications needs to be included. All the manufacturing sites, including the suppliers and sub-contractors must be identified in the technical documentation.
- General safety ad performance requirement
This section is links to Annex I and shows which general safety and performance requirement apply to the medical device. The presentation of methods which used to demonstrate conformity must be defined. This section must include the presentation of the relevant harmonized standards, specification or other rules and reference to controlled documents and records of evidence.
- A risk management file
A risk management file is the result of an implemented risk management system, the process of which are described in ISO 14971 standard. The risk management file includes management plan, risk analysis and risk control measures and a risk management report, which contains an assessment of the risk-benefit ratio.
- Verification and validation of the device
In this section, the documents demonstrate conformity of the device with the MDR and in particular with the applicable general safety and performance requirements. The presented results and critical analysis are supported with various verification and validation tests, examinations, studies, etc. These clinical and preclinical data also include also test design, protocols, methods of data analysis. Depending on the type of the device, biocompatibility, physical, chemical, and microbiological characterization, electrical safety and electromagnetic compatibility, software verification and validation, stability, performance, and safety etc. should be presented. Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council shall be demonstrated.
Requirements for documentation in Annex III
The MDR goes one step further as it includes post-market surveillance, which requirements are established in Annex III. The manufacturer must collect the following information: incidents, side-effects, trend reports, literature data, feedback and complaints, information on similar medical devices. The manufacturer must systematically collect information and, if necessary, initiate corrective measures. They must also include a Post-Market Clinical Follow-Up Plan (PMCF) and the periodic safety update report (PSUR).
Medical Device Regulation (MDR) 2017/745 provides guidelines as to which content must be presented in the technical documentation submitted for approval of a medical device, however, it does not give explicit information in terms of structure and uniformity of the documents. It only states that manufacturer of a medical device must prepare clear, organized, readily searchable and unambiguous technical documentation. However, it would be of benefit to authorities as well as manufacturers if the MDR would give information on a uniform structure of the technical documentation, similar to eCTD for medicinal products.
