P
Pakos
Going back to the basics:
The system needs to be CE-certified because that is a medical device, the legal manufacturer is responsible for this. In your case the system is not your system but the organ builders system. The system manufacturer might rely on you as a component producer for relevant information (e.g. EMC, safety) but he is responsible.
You as a component producer can decide to be a legal manufacturer (when you fulfill MDD criteria). Probably you will not manufacture a medical device, but an accessory of a medical device that can be CE certified at its own (a medical device needs to be certified). Sometimes this is done because you intend to sell your accessory to various componies and the own CE marking can make their life more easy. The system manufacturer can use article 12 for system packs to simplify the CE marking.
Then going back to the subcontractor that you use. This component is critical for the functioning of the device (without this it would not function). In the end the total system should fulfill safety and EMC requirements. Therefore the complete system (incl components) is to be tested against applicable standards.
An alternative route here might be when you do not deliver that specific component but the user can buy a component themselves. Then you must assure that that you fulfill the EN60601-1-1 requirements for systems. Does the user use a component that is tested against medical standards and fulfills your specifications, did you take enough protective measures....
Hope this gives an overview.
The system needs to be CE-certified because that is a medical device, the legal manufacturer is responsible for this. In your case the system is not your system but the organ builders system. The system manufacturer might rely on you as a component producer for relevant information (e.g. EMC, safety) but he is responsible.
You as a component producer can decide to be a legal manufacturer (when you fulfill MDD criteria). Probably you will not manufacture a medical device, but an accessory of a medical device that can be CE certified at its own (a medical device needs to be certified). Sometimes this is done because you intend to sell your accessory to various componies and the own CE marking can make their life more easy. The system manufacturer can use article 12 for system packs to simplify the CE marking.
Then going back to the subcontractor that you use. This component is critical for the functioning of the device (without this it would not function). In the end the total system should fulfill safety and EMC requirements. Therefore the complete system (incl components) is to be tested against applicable standards.
An alternative route here might be when you do not deliver that specific component but the user can buy a component themselves. Then you must assure that that you fulfill the EN60601-1-1 requirements for systems. Does the user use a component that is tested against medical standards and fulfills your specifications, did you take enough protective measures....
Hope this gives an overview.
