Regulatory Affairs
Technical Documentation Europe
Preparation of technical documentation for Medical Devices
Many manufacturers perceive the creation of Technical Documentation as a necessary evil. If you don't act carefully in this process, you risk time-consuming and costly follow-up questions and additional charges.
The three most frequently asked questions when creating the Technical Documentation:
- What are the additional requirements for Technical Documentation according to the MDR?
- Is there a format template or a kind of sample structure that can be used as a guideline?
- Is Clinical Evaluation/Performance Evaluation needed?
The structure of technical documentation
It is not necessary, nor helpful, to submit all the documents "that you have". Technical Documentation only contains documents that are needed and explicitly requested.
There is no mandated structure for the Technical Documentation. However, there are requirements for this structure, which are also described in Annex II of both regulations.
However, there are formats, such as the STED format, which can be used. However, it is not wrong to create your own structure as long as it fulfills the requirements in Annex II.
Depending on
- in which target areas a company operates,
- which portfolio is available and
- how dynamic the product development of a manufacturer is,
various solutions for structuring and formatting Technical Documentation to keep the maintenance effort as low as possible and to avoid anxiety.
Discover our "TrendReport" service
Full service for the reporting of trends in accordance with Art. 88 of the MDR. Learn more about TrendReport.
We create your structures
Wouldn't it be wonderful to have a structure in which you can store all information and documents, which is easy to maintain and at the same time "reusable" in different target markets? There is! And the best thing is: you don't have to adapt to the structure, we adapt it to you - to your portfolio and your target markets.
We can help!
Follow us on these pages and we will show you how we can support you. And feel free to take advantage of our free offers such as
