The difference between a Medical Device Accessory and Component

S

snoopy2017

I would like to know what the difference is between a component and an accessory. For example, can a piece of software be classified as a component of a system or an accessory, which is outside the system?
 
S

snoopy2017

Accessory and Component

Under European regulations, I would like to know what the difference is between a component and an accessory. For example, can a piece of software be classified as a component of a system or an accessory, which is outside the system?

Thank you so much.
 

QAengineer13

Quite Involved in Discussions
Re: Accessory and Component

Under European regulations, I would like to know what the difference is between a component and an accessory. For example, can a piece of software be classified as a component of a system or an accessory, which is outside the system?

Thank you so much.

Hi Snoopy2017,

If you are interested in the EU market please refer to this guidance MEDDEV2.1/1 Defintion of "medical device","accessory" and "manufacturer"

DocsRoom - European Commission

For Qualification and Classification of stand alone software, pelase refer to this link MEDDEV 2.1/6
DocsRoom - European Commission


Probably you will find an answer after reading this, if it still doesnt clear your question,then the forum members will be able to help...enjoy reading!
 
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