Non-medical device accessory for a medical device

[JoCam]

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

 

[Nash27]

Company A’s product not necessarily be supplied as a medical device because it would fix into company C’s medical device. Company C will be responsible to address all aspects of weighing scale when fitted to class I medical device. I prefer term as a ‘component’ for weighing scale.

Company A does not need to supply any documents for the product being CE marked as it is the company C that is going to manufacture the product as class I device (that has weighing scale as a component or an accessory)

Being a manufacturer of medical device company C require to meet medical device requirements which they can satisfy themselves or ask help or dictate to company A for information such as weighing scale tolerances, calibration requirements, accuracy etc.

Company C would be questioned for the device compliance from regulator, company A would be considered as a supplier. So company C need to ensure that company A complies with the weighing balance requirements and has adequate control over their sub-contractor i.e. company B.

I hope this would help.

 

[somashekar]

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

Will the company C ever sell that weighing scale separately packaged and labelled for the patient or user to buy and use it along with the class 1 medical device ... ?

 

[JoCam]

Hi Nash27,

Thank you for your response, and I have some further questions;

Does Company C have to be informed of the weighing system being designed to fit on and off their class I medical device?

Company A has approached Company B to make the weigh scales to fit onto company C's medical device. Company C has had no input whatsoever, and will not be involved in the manufacture of the weigh scales. Should they have been involved, and would Company A be able to CE mark and sell or rent this weigh scales as the legal manufacturer?

Regards,

Jo

 

[JoCam]

Hi Somashekar,

The plan is that Company C will not be getting their hands on the weigh scales. This will be sub-contract manufactured by Company B for Company A, who will sell/rent it with the Class I medical device manufactured by Company C.

Jo

 

[dgrainger]

To be an "accessory" the product must enable the device manufactured by manufacturer C perform as intended. Manufacturer C must state that there is a requirement for the accessory.

‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;​

 

[Nash27]

Hi Nash27,

Thank you for your response, and I have some further questions;

Does Company C have to be informed of the weighing system being designed to fit on and off their class I medical device?

Company A has approached Company B to make the weigh scales to fit onto company C's medical device. Company C has had no input whatsoever, and will not be involved in the manufacture of the weigh scales. Should they have been involved, and would Company A be able to CE mark and sell or rent this weigh scales as the legal manufacturer?

Regards,

Jo

It depends who intend to be manufacturer, if C is intended to put their name as a manufacturer then they need to meet compliance requirements of medical device including the weighing scale. Company C would not be necessarily needed to get involved in relation to weighing scale design activity, it can be done as part of the package (sales contract/ quality contract). However, they need to get the required design / compliance details from company A when required and such this should be stipulated in a quality agreement.

If company A intend to be legal manufacturer and supply the weighing scale as a component to fit the class I medical device then they need to register the weighing scale as a medical device. In this scenario company A need to comply with weighing scale requirements plus regulatory requirements (CE marking).

In context with company C:- Company C can buy or rent the weighing scale, still they are obliged to meet the weighing scale requirements because it is component of class I medical device.

Another alternative is selling as a procedure pack / system in that company A and company B can combine their products by individually registering products as a medical device and company C can sell the product as a manufacturer.

 

[JoCam]

Hi Nash27,

Company A holds stock of Company C's medical device (which is a bed by the way) as a part of their rental service, and it is as a result of customer feedback that Company A has worked with Company B to develop a weigh scales that can be fitted to it.

With this in mind, can Company A CE mark the scales for use with this bed without having to involve Company C?

Regards,

Jo

 

[dgrainger]

For what purpose is the weighing scale? I'm assuming that it is for weighing the patient but for what purpose?
If it isn't intended for a "diagnostic/clinical purpose", it doesn't sound like it is a device?

BTW It doesn't enable the functioning of a bed so can't be classified as an accessory.

 

[Ronen E]

BTW It doesn't enable the functioning of a bed so can't be classified as an accessory.

This is likely true however instead of a statement I would ask “what is the intended use of the bed, as declared / implied by C?” Some medical beds are quite sophisticated these days. Hypothetically the original bed could have a weighing element that doesn’t function properly / is inconvenient to use / whatever, and the renter might decide that they would benefit from a retrofit to replace it (to actually enable the original intended use).

This thread is an excellent demonstration why details from the OP matter, for us to be able to provide meaningful (and hopefully useful) answers.