List of Contributions

Anoop, In most countries, there is no requirement to include the distributor name on the product labelling. Inclusion of a distributor name on the labelling is really a business decision between the two companies. However, make sure the labelling is clear who is the Manufacturer because if another ...

Hello Haewon, It really depends on what these accessories are doing, functionality, and how they may assist in the main application in its functionality.  If you are speaking about the Software as Medical Device (SaMD) and these accessories are also only software, then it does depend on function and ...

Hi Lukas, Yep, I have seen that before too - peer-reviewed journals need to have their own traceability.  An "internal" study that a company says, 'yep the data is good!' does not really go well with peer-reviewer journals haha.  The issue is a PMCF is not a formal study outside of the company.  The ...

Hello Lukas, The question raised with registering a PMCF in a clinical study database like eudraCT is PMCF is a "study" with already approved medical device - the device is CE Marked.  Therefore it is completely acceptable to be used for humans/patients.  As far as I know, there is no requirement ...

Hello Lukas, You can not really choose between 510(k), De Novo or PMA, it all depends on the classification of the device: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.  Because you may think the device is a higher risk or higher classification, does not necessarily ...