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Technical Documentation
Technical documentation for medical software & apps
Documentation for medical devices
Technical documentation for medical devices, including medical software & apps, is the generic term for product documentation. Technical documentation includes at least all documents that manufacturers of medical devices must provide in accordance with the Medical Device Regulation (MDR - EU 2017/745).
Our team specializes in creating technical documentation specifically for medical software and apps. The content of this documentation is complex, as you will soon discover. However, we are here to alleviate the burden and effort involved by offering a range of services.
Services for the technical documentation of medical software
Select the services that best meet your current needs for technical documentation of medical software:
- Consultation and assistance with your technical documentation
- Creation of technical documentation
- Gap analysis: Review of existing technical documentation to ensure compliance with necessary approval requirements
- Revision of technical documentation to address any deviations found during audits
Now, let us discuss the most crucial aspect - the content of your technical documentation. Our team can offer expert advice and support in this area.g.
Contents of the technical documentation for medical devices
Annex II and III of the Medical Device Regulation (MDR) specifically describe the content that must be included in all technical documentation for medical devices.
This includes clear identification and description of medical devices. The form in which the medical device works and the functional elements with which it performs its function should be clearly described.
This includes, for example, a general description of the medical device, the product variants and the intended purpose; UDI (Unique Device Identification); categorisation and classification of the medical device; declaration of conformity and description of the mode of operation.
Manufacturers must provide users with information on how to safely identify and use the medical device in accordance with its intended purpose.
This should include a description of the development process, design phases, results of milestones, and names of all organizations involved. Production and quality control should also be presented in a clear manner.
Manufacturers must demonstrate how their medical device meets applicable requirements or explain why certain requirements do not apply.
The following points must be explained:
- Justification of the applicability / non-applicability of the requirement
- Reference to common specifications
- Standards or parts thereof (specific indication of the respective issue status)
- Reference to controlled documents and records as proof of fulfilment
- Assessment of whether the requirements are met
- A List of applied standards and common specifications should also be included
In addition to the risk analysis, the entire risk management must be presented here. This should include information on planned medical devices, identified risks, and measures taken to reduce risks.
The following documents are required for this:
- Risk management plan
- Analysis of the risks with risk control measures
- Risk management report including the assessment of residual risks
- and the assessment of the risk-benefit ratio
Verification and validation are based on the specifications of the medical devices and their properties.
The technical documentation on post-market surveillance focuses on the following: Post-market surveillance plan; post-market surveillance report (class I) and periodic safety update report. The clinical evaluations may need to be updated if the post-market surveillance has not collected sufficient data and a post-market clinical follow-up needs to be planned and conducted.
Regularly update or supplement technical documentation
Manufacturers are responsible for continuously updating and supplementing their medical device documentation throughout the entire life cycle of their products. This includes systematically and actively collecting information about their products after they have been placed on the market, to keep their technical documentation up to date. Depending on the type and service life of the products, this can be a time-consuming process. The level of effort required also depends on the classification of the medical device.
- For class I medical devices, the safety report must be prepared but updated only if necessary.
- The scope of the report is greater for class IIa, IIb and III medical devices. There is also a fixed period in which the report must be updated. For class IIa devices, this is the case when required or after two years at the latest. For class IIb and III devices, manufacturers must update the report as required, but at least once a year.
Future creation of technical documentation
The technical documentation and the content required to create the documents are created together with the product during development. It therefore makes sense to integrate the editing of technical documentation into the company's internal processes.Our quality management team will be happy to support you with this. Simply contact us using the contact form below.
Aim and purpose of the technical documentation
The aim of the technical documentation is to provide evidence that the basic safety and performance requirements for a medical device have been met, i.e. that the medical device complies with the Medical Device Regulation.
The purpose of the technical documentation is to inform and instruct the users, protect the manufacturer from liability, monitor the product, to ensure traceability and reproducibility and to archive the information.
This documentation must always be available, regardless of the medical device class. As the technical documentation must also fulfil the requirements of the authorities to obtain CE conformity for the medical device and to be able to place the product on the market in the European Economic Area. For class Is, Im, Ir devices, the technical documentation must also fulfil the requirements of the notified body (e.g. TÜV) at least in part; for class IIa, IIb and III devices, it must fulfil these requirements in full.
Why is the technical documentation important for authorisation?
The technical documentation is a crucial component in the authorization process for medical devices. Without it, manufacturers cannot conduct a conformity assessment and obtain product authorization. Additionally, authorities may request either the entire documentation or a summary, making it essential to maintain compliant technical documentation.
The Medical Device Regulation, which has been in force since 26 May 2021, not only specifies requirements for the product, but also for the documentation itself.
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