Take advantage of the MDR transition: How to save time with complete technical documentation
Until the end of the MDR transition period – when manufacturers must have converted their medical devices to the new Medical Devices Regulation – is there still some time? Theoretically, yes, but it is advisable not to take too much time. Why?
For one thing, there is still an approval backlog at the Notified Bodies due to capacity problems. The number of MDR-certified Notified Bodies is small – the longer the waiting times until approval. At the same time, the workload has also increased enormously for the Notified Bodies due to the new MDR.
On the other hand, you as a manufacturer must of course also plan for reworking the technical documentation when you finally receive the deviation report from the notified body. So there are at least two good reasons to deal with the rapid transfer of your medical devices.
Our advice for saving time when creating technical documentation:
In this way, you avoid redundancies and deviations that cost you additional time until the end of the MDR transition.
How does the technical documentation become complete?
The greatest potential for error in the creation of technical documentation lies in decentralised documents – and the use of spreadsheet tools as a digital solution. In short: Technical documentation becomes seamless if you digitise processes and information centrally and manage them in a traceable way. Linking individual data additionally accelerates the process without the need for manual effort.
Specialised software solutions support you on the way to seamless technical documentation. This is because they facilitate the work in a web-based environment in which you record relevant data.
Make sure that the software solution supports you with all the time-saving tips:
(interdisciplinary) teamwork
dynamic links between elements
centralised knowledge (single source of truth)
traceable change histories
simplified monitoring
Why is a complete technical documentation so important?
Every gap in your technical documentation offers the Notified Body the opportunity to identify deviations. The larger the deviation report becomes, the more time-consuming your reworking of the document will be and the longer the approval procedure will take.
It is therefore all the more important that you now actively use the remaining time until the end of the MDR transition period. Depending on the risk class of the medical device, the transition periods also vary. The following applies:
MDR transition - timeline
Implants (risk class III): Extension until 2026, May 26
Risk classes III and IIb: extension until 2027
Risk classes I and IIa: extension until 2028
How do you ensure that your technical documentation complies with the MDR requirements?
Specialized software solution – are the two magic words that answer this question. Our solution for you: BAYOOSOFT Themis with its Documentation Guide module.
With the standard-compliant solution in accordance with MDR and IVDR, you are guided through the workflow during creation. No gaps are left open.
All information is entered centrally in one place. Your information is interactively linked with each other, so you avoid contradictions and the repeated entry of the same data. With the change history and dashboards, you can track the work and get an overview of the progress.
To finish? Once all the information has been entered, you receive the initial document for the Notified Body, which bundles all the individual documents.
Goodbye decentralised tables: Who we have already convinced of BAYOOSOFT
Dr. Robert Zinke from biotrics bioimplants AG talked to us about how our software solution supports technical documentation in everyday work.
In the video you can find out how biotrics bioimplants went about selecting and implementing the solution – and why they would not want to do without our BAYOOSOFT solution.