Use the MDR transition period: How to save time with complete technical documentation
Is there still some time until the end of the MDR transition period – when manufacturers must have converted their medical devices to the new Medical Device Regulation? Theoretically yes, but it is advisable not to take too much time. Why?
On the one hand, there is still an approval backlog at the notified bodies due to capacity problems. The number of MDR-certified notified bodies is low – the longer the waiting times for approval. At the same time, the workload for notified bodies has also increased enormously as a result of the new MDR.
On the other hand, you as the manufacturer must of course also plan for reworking the technical documentation when you finally receive the non-conformity report from the notified body. In other words, there are at least two good reasons to consider the rapid transfer of your medical devices.
Our tip for saving time when creating technical documentation:
How does the technical documentation become complete?
The greatest potential for error in the creation of technical documentation lies in decentralized documents – and the use of spreadsheet tools as a digital solution. In short, technical documentation becomes seamless when you digitize processes and information centrally and manage them in a traceable manner. Linking individual data additionally speeds up the process without the need for manual effort.
Specialized software solutions support you on the way to seamless technical documentation. This is because they make it easier to work in a web-based environment in which you record relevant data.
Make sure that the software solution supports all time-saving tips:
Why is complete technical documentation so important?
Any gap in your technical documentation gives the Notified Body the opportunity to identify deviations. The larger the deviation report, the more time-consuming your reworking of the document will be and the longer the approval process will take.
It is therefore all the more important that you actively use the remaining time until the end of the MDR transition period. The transition periods also vary depending on the risk class of the medical device. The following applies:
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.
The standard-compliant solution in accordance with MDR and IVDR guides you through the creation workflow. No gaps are left open.
You record all information centrally in one place. Your details are linked interactively, so you avoid inconsistencies and having to enter the same data several times. With the change history and dashboards, you can track the work and get an overview of progress.
To conclude? Once all the information has been entered, you will receive the initial document for the Notified Body, which bundles all the individual documents.
