It helps me to understand the definition of accessory and medical part/component，but still, if an accessory is regulated by mdr, should it be in the same class with my main device? what should I put on the lables ? What certificate should NB give me if it is not a medical device?
Great video! One piece that wasn’t covered is how to apply to classification rules to accessories when their intended use is to enable a medical devices intended use?
Sorry but I could not derive a clear answer from the question: "Do accessories need to be labeled with MD symbol?" According to ISO 15223-1 it is only to be used for "medical devices" but in multiple forums it is stated that accessories are considered "devices" and therefore should be labeled with the MD symbol. Could you please state your position on that.
Monir - thank you for this, it is a interesting topic that raises many questions. Good to see it being covered.
Thanks Beyan, you‘re welcome.
It helps me to understand the definition of accessory and medical part/component，but still, if an accessory is regulated by mdr, should it be in the same class with my main device? what should I put on the lables ? What certificate should NB give me if it is not a medical device?
Great video! One piece that wasn’t covered is how to apply to classification rules to accessories when their intended use is to enable a medical devices intended use?
Sorry but I could not derive a clear answer from the question: "Do accessories need to be labeled with MD symbol?" According to ISO 15223-1 it is only to be used for "medical devices" but in multiple forums it is stated that accessories are considered "devices" and therefore should be labeled with the MD symbol. Could you please state your position on that.
Thanks , helped a lot
You're welcome!
interesting info
Thanks!