Technical Documentation for Medical Devices
The term technical documentation (or technical file) refers to all the documents that a medical device manufacturer has to submit. The technical file is a requirement for the conformity assessment and, therefore, for the approval of medical devices.
1. Regulatory requirements for the technical documentation
a) Medical Device Directive 93/42/EEC (MDD)
The Medical Device Directive (93/42/EEC) specifies requirements for medical devices, including the so-called essential requirements. Manufacturers are legally obliged to demonstrate compliance with these requirements. This compliance is demonstrated through the technical documentation (also called the TD or “technical file”).
The Medical Devices Directive (in contrast to the MDR) does not specify the requirements for the documents themselves that precisely. However, it mentions: They must include, for example:
- A general description of the product, including any variants planned and its intended use;
- The design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfill the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full;
- The techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed;
- If the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer;
- The solutions adopted in accordance with Annex I Chapter I Section 2;
- The preclinical evaluation;
- The clinical evaluation referred to in Annex X;
- The draft label and, where appropriate, instructions for use.
All these documents must be submitted by manufacturers during the conformity assessment procedure - as technical documentation.
b) Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) does not just define requirements for the device (Annex I), it also defines the requirements for the documentation itself (Annex II). This must include (see Fig. 1):
- Identification of the device (e.g. with a UDI)
- Description of the device, including variants, configuration and accessories
- intended use
- Labeling (packaging, instructions for use, etc.)
- Information on the design and manufacture of the device
- Risk management file
- Verification and validation of the device and, therefore, proof that the device meets the general safety and performance requirements.
Fig. 1: The MDR specifies the requirements for the technical documentation in Annex II (click to enlarge)
The MDR goes one step further: It includes the post-market surveillance, with its planning and implementation, under technical documentation. It establishes the corresponding requirements in Annex III.
c) ISO 13485:2016
The 2016 version of ISO 13485 introduced the medical device file. This file must provide similar information:
- Description of the device
- Intended purpose
- Labeling (packaging, marking, instructions for use, installation and maintenance instructions)
- Device specification
- Specifications for its manufacture, packaging and storage
- Market surveillance
- Proof of conformity, including verification and validation
d) Notified bodies
The notified bodies have also published recommendations, such as NB-MED/2.5.1. These publications have no legal force. However, their contents are nevertheless regularly requested during audits and reviews of the technical documentation.
The FDA also requires detailed device documentation. It differentiates between several files:
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
The Canadian authorities have published their own idea of the structure of the technical documentation based on the STED structure.
2. Contents of the technical documentation
The above regulations define the aspects that the technical documentation must contain. But it does not describe:
- Specific content, e.g. what does a software architecture or the biocompatibility testing have to describe?
- The distribution of the content across the documents
- The structure of the documents (chapter structure)
The standards, such as ISO 14971, IEC 62304, IEC 60601-1 and IEC 62366-1, do give detailed specifications for the content. So, ISO 62366-1 specifies that the documentation must include the planning of a formative assessment. You won’t find such granular requirements in the MDD, MDR, or ISO 13485.
The following mind map provides a summary and an overview of the documents that medical device manufacturers must prepare for a conformity assessment to demonstrate that their medical devices meet the essential requirements according to Annex I of the Medical Device Directive.
Fig. 2: Mindmap with contents of the technical documentation. You can download a translated version free of charge as part of the starter kit.
3. Structure of the technical documentation
The regulatory requirements do not specify how manufacturers should structure the technical documentation. One exception is the FDA, which for example provides the chapter structure including chapter numbering for premarket notifications (510(k)).
a) Objectives of a “standardized” structure
Some "associations" have drawn up proposals for the structure of the technical documentation to try to achieve the following objectives:
- Manufacturers can get an overview as quickly as possible as to what they have to document.
- The authorities and notified bodies can quickly find their way around and review the technical documentation thanks to a uniform and logical structure.
- Manufacturers have to expend less effort on re-writing the files for different legal fields.
b) Proposals for the structure of the technical documentation
STED: Summary Technical Documentation
One of the best known proposals for structuring technical documentation comes from the IMDRF (formerly the GHTF). A lot of authorities and notified bodies use the STED (Summary Technical Documentation) as a guide.
The Association of Southeast Asian Nations (ASEAN) has also published a proposal for the structure of the technical documentation, the Common Submission Dossier Template (CSDT).
This ASEAN CSDT is called “Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN Common Submission Dossier Template”.
Fig. 3: Structure of technical documentation according to the ASEAN CSDT (click to enlarge)
The proposal of the NB team set out in the document NB-MED 2.5/1 is also relevant in practice.
Fig. 4: Structure of the technical documentation according to the NB team.
The structure shown in Fig. 2 is particularly suitable for manufacturers of active medical devices: It is compact, easy to understand and suitable for meeting the regulatory requirements.
4. Compilation of the TD for different legal systems
Many, but not all, international authorities accept standardized formats, such as STED. Nevertheless, there are country-specific differences.
To ensure that manufacturers do not lose track, we recommend using a “mapping table” containing all the documents or aspects that have to be addressed in the respective legal systems.
Table of contents
VOL 023 Appendix-B Requirements Specification
02 Device Description
Fig. 5: Table comparing the documents and requirements of different legal systems
The columns, which represent the structures named above, describe where in which file the content can be found.
The task of maintaining such tables and compiling the approval the specific approval documents for each individual market would be the responsibility of the Regulatory Affairs department. The content, on the other hand, must be created by the appropriate specialist departments.
5. Interaction between the technical documentation & the QM system
The manufacturers must always draw up the technical documentation for their medical devices and (except for class I devices) submit it to the notified bodies. There it will be checked for the first time. The technical documentation is also the subject of ISO 13485 audits. Based on this documentation, the auditors assess not only whether the basic requirements of the Medical Device Directive have been complied with, but also whether the manufacturers are working in conformity with their own quality management system. Finally, the QM system must define the processes (e.g. for development and risk management) that are used to develop and produce medical devices.
Therefore, the technical documentation (or the technical file) is not just something that the manufacturers have to compile and submit to the notified bodies, it is more a set of documents that are written “automatically” during the development process.
In other words: Without a consistent, standard-compliant and complete technical documentation, medical device manufacturers cannot prove that their medical device meets the essential requirements or that their QM system is effective. For most manufacturers, the QM system is the prerequisite for the conformity assessment.
6. Support for the preparation of technical documentation
The Johner Institute specializes in helping medical device manufacturers create technical create technical documentation.
- The video trainings in Auditgarant show you step-by-step how to create your documentation quickly and without QM bureaucracy. Additional templates and sample documents are available for premium members.
- Our team of consultants helps with writing and reviewing technical documentation, e.g.:
- Risk management file
- Software file (software requirements, software architecture, tests)
- Usability file
- Clinical evaluation
- Documents for FDA approval
Do you have any questions? Do you need some help? We are happy to help, quickly and cost-effectively. Find out more!