Hi All,
Here's the scenario: Company A would like to sell a non-medical device weigh scales in Europe, that has been sub-contract manufactured by Company B (under Company A's direction) specifically to fix onto a class I medical device manufactured and supplied by Company C.
I have a number of questions: -
I'm assuming that because the weigh scales has been made specifically to fix onto the class I medical device, that it becomes an accessory to that medical device, and therefore becomes a medical device. Is this correct?
Will Company A need any documents from the manufacturer of the class I medical device (Company C) to be able to CE mark the accessory?
In order to CE mark the weigh scales as an accessory, as well as all that needs to be done for whichever class the weigh scales falls into, will Company A need to consider continued compliance with the standards applicable to the Class I medical device manufactured by Company C, and can this be done without informing/contacting Company C?
These are my starters for 10, I'm really having difficulty with this one.
Any help will be greatly appreciated.
Jo
Here's the scenario: Company A would like to sell a non-medical device weigh scales in Europe, that has been sub-contract manufactured by Company B (under Company A's direction) specifically to fix onto a class I medical device manufactured and supplied by Company C.
I have a number of questions: -
I'm assuming that because the weigh scales has been made specifically to fix onto the class I medical device, that it becomes an accessory to that medical device, and therefore becomes a medical device. Is this correct?
Will Company A need any documents from the manufacturer of the class I medical device (Company C) to be able to CE mark the accessory?
In order to CE mark the weigh scales as an accessory, as well as all that needs to be done for whichever class the weigh scales falls into, will Company A need to consider continued compliance with the standards applicable to the Class I medical device manufactured by Company C, and can this be done without informing/contacting Company C?
These are my starters for 10, I'm really having difficulty with this one.
Any help will be greatly appreciated.
Jo