ISO 13485 definition of Medical Device - "Material" or "Article"

ISO 13485 defines medical device as:

"any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, ....."

Question is: How to define "material" or "article"? Is a switch on a patient monitor medical device? What about a wire?

PS: The FDA has finished device, which is the "plug and use" type and unfinished device which sometimes is called component. GMP requirements on finished and unfinished device differ.

treesei said:

ISO 13485 defines medical device as:

"any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, ....."

Question is: How to define "material" or "article"? Is a switch on a patient monitor medical device? What about a wire?

PS: The FDA has finished device, which is the "plug and use" type and unfinished device which sometimes is called component. GMP requirements on finished and unfinished device differ.

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I think that the answer to your question is what I higlighted above. Parts of a device is an article, so yes, a switch or a wire etc. is articles.

Then in regions like Europe where ISO 13485 is a must for medical device manufacturers, it is true that the wire or switch manufacturer must comply with ISO 13485?

treesei said:

Then in regions like Europe where ISO 13485 is a must for medical device manufacturers, it is true that the wire or switch manufacturer must comply with ISO 13485?

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ISO 13485 is not a requirement. Nowhere in the MDD is that stated. We've had these discussions.

Let me re-phrase: If ISO 13485 is a requirement in a region/country, must this wire/switch manufacturer comply with it?

Or: Under the definition of ISO 13485, will this wire/switch manufacturer be considered a medical device manufacturer?

treesei said:

Let me re-phrase: If ISO 13485 is a requirement in a region/country, must this wire/switch manufacturer comply with it?

Or: Under the definition of ISO 13485, will this wire/switch manufacturer be considered a medical device manufacturer?

Click to expand...

If you are a sub-supplier, then you are not a medical device manufacturer. If you manufacture the finished product then you need to have the appropriate controls in place for each component of the device.

Treesei,

If your question is particularly for manufactureres of switches and wires, those are not medical devices, as they are not specifically for the following -

 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices,
 providing information for medical purposes by means of in vitro examination of specimens derived from the human body

In my case, we expect our suppliers to have a documented and effective quality management system capable of meeting the ISO 9001 standard but if he has ISO 13485 system, thats a BONUS