Dear members,
I'm on the final stage of obtaining the CE mark for a bioceramic bone substitute. In a preliminary analysis of the technical file our notified body has raised a non conformity stating "No usability file seen".
The problem is that IEC 62366-1 defines “usability” has “a characteristic of the user interface” which in turn can be defined has a way to communicate with a device. Taking into account that the medical device is a ceramic, it has no measuring functions, it does not extract or displays any kind of information, it has no ergonomic features and it is not possible to establish any kind of communication with the device (it does not receive inputs and/or gives outputs). Moreover it will be resorbed by the body and will disappear in a few months.
Thus, it is my understanding that the device has no “user interface” and by definition no “usability”. It is obvious that some "communication" is established through the labelling but those risks are under the risk management process.
Do you think IEC 62366-1 applies to 3D resorbable bone substitutes (blocks, wedges, granules)?
If so, can you provide an example?
If not, how can I explain that to the notified body? (they did not accepted the above interpretation...)
Thank you
I'm on the final stage of obtaining the CE mark for a bioceramic bone substitute. In a preliminary analysis of the technical file our notified body has raised a non conformity stating "No usability file seen".
The problem is that IEC 62366-1 defines “usability” has “a characteristic of the user interface” which in turn can be defined has a way to communicate with a device. Taking into account that the medical device is a ceramic, it has no measuring functions, it does not extract or displays any kind of information, it has no ergonomic features and it is not possible to establish any kind of communication with the device (it does not receive inputs and/or gives outputs). Moreover it will be resorbed by the body and will disappear in a few months.
Thus, it is my understanding that the device has no “user interface” and by definition no “usability”. It is obvious that some "communication" is established through the labelling but those risks are under the risk management process.
Do you think IEC 62366-1 applies to 3D resorbable bone substitutes (blocks, wedges, granules)?
If so, can you provide an example?
If not, how can I explain that to the notified body? (they did not accepted the above interpretation...)
Thank you