Hello,
I am currently despairing over the discussion of the requirements for market surveillance of a medical device that is sold through discounters. For the PSUR, I always look at the product reviews on the discounter websites and esp evaluate negative reviews. But if I have a significant proportion of a plausible positive feature, that I can possibly back up with other data, I am happy to use this information for my own product too. At the same time, I look for equivalent products on these websites too.
Now, however, my customer complaints, that I should stop doing this unnecessary work of checking the respective websites as it would be utter nonsense to use such information - The argument was, that if it was a justified and serious complaint, the people affected would have contacted the retailer or manufacturer indicated on the packaging and not writte something on the product website. I absolutely don't share this opinion at all, it's the easiest way for the user, and not everyone will use it either, as it also requires effort and then the product will be simply thrown away without anyone knowing that there was an undesirable effect. In this respect, I think that undesirable effects are generally under-reported in products sold to lay people this way, but the website at least provides the best insight, or maybe also the pages of other large online shops.
I was asked to ignore all of these data or quote, where the requirement to do this (check the product websites for reviews and then use them) is clearly given. There are such requirements given in detail, but they relate more to equivalent products - the reference to databases was of no help here, as it is believed that this only refers to the national database with the recall reports, which I have already checked. However, there will be hardly any lubricants listed, that don't glide, but stick or cause skin irritation. I would have said, that this is due to the nature of such products and that individual reactions are not necessarily an incident and thus published in the national database. But nevertheless gives me information to improve my product or evalutate if I have missed a risk, which is the fundamental reason to perform the PSUR and thus is for me reason enought to check these product ratings.
So if anyone has a good reason (MDR or guidance citing), why such website product evaluations should be used for the PSUR, I would be very grateful
I would also be happy to hear your opinion on this or which data sources do you use for medical products for use by laypeople that are sold via discounters?
I am currently despairing over the discussion of the requirements for market surveillance of a medical device that is sold through discounters. For the PSUR, I always look at the product reviews on the discounter websites and esp evaluate negative reviews. But if I have a significant proportion of a plausible positive feature, that I can possibly back up with other data, I am happy to use this information for my own product too. At the same time, I look for equivalent products on these websites too.
Now, however, my customer complaints, that I should stop doing this unnecessary work of checking the respective websites as it would be utter nonsense to use such information - The argument was, that if it was a justified and serious complaint, the people affected would have contacted the retailer or manufacturer indicated on the packaging and not writte something on the product website. I absolutely don't share this opinion at all, it's the easiest way for the user, and not everyone will use it either, as it also requires effort and then the product will be simply thrown away without anyone knowing that there was an undesirable effect. In this respect, I think that undesirable effects are generally under-reported in products sold to lay people this way, but the website at least provides the best insight, or maybe also the pages of other large online shops.
I was asked to ignore all of these data or quote, where the requirement to do this (check the product websites for reviews and then use them) is clearly given. There are such requirements given in detail, but they relate more to equivalent products - the reference to databases was of no help here, as it is believed that this only refers to the national database with the recall reports, which I have already checked. However, there will be hardly any lubricants listed, that don't glide, but stick or cause skin irritation. I would have said, that this is due to the nature of such products and that individual reactions are not necessarily an incident and thus published in the national database. But nevertheless gives me information to improve my product or evalutate if I have missed a risk, which is the fundamental reason to perform the PSUR and thus is for me reason enought to check these product ratings.
So if anyone has a good reason (MDR or guidance citing), why such website product evaluations should be used for the PSUR, I would be very grateful
I would also be happy to hear your opinion on this or which data sources do you use for medical products for use by laypeople that are sold via discounters?
