Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW

#1
Hi,
Does the regulation differentiate in any way (in terms of definition/role/responsibilities) between the legal manufacturer of a medical device and the legal manufacturer of a SaMD/MDSW under MDR?
Thanks.
 
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yodon

Staff member
Super Moderator
#2
Are you maybe confusing developer and manufacturer? The manufacturer "...markets that device under its name or trademark." If you're the entity distributing (and responsible for postmarket stuff, etc.; i.e., who the regulatory bodies hold responsible) then you're the manufacturer. If you contract out development of software (whether SaMD or integrated into a physical device), you're still the manufacturer (and responsible for all regulatory aspects of that software).

Does that clarify?
 
#3
Are you maybe confusing developer and manufacturer? The manufacturer "...markets that device under its name or trademark." If you're the entity distributing (and responsible for postmarket stuff, etc.; i.e., who the regulatory bodies hold responsible) then you're the manufacturer. If you contract out development of software (whether SaMD or integrated into a physical device), you're still the manufacturer (and responsible for all regulatory aspects of that software).

Does that clarify?
Erm.. not exactly, but it does confirm my understanding. Actually my question wasn't clear enough, my bad!
So this is the case- a manufacturer wants us (we will be developing the software for their device) to also be the legal manufacturer. Now, I remember reading that a device can have more than one legal manufacturers and each of them will have regulatory responsibility for the device.
So my question was, is there any difference when it is not a usual medical device but an SaMD? Basically, am not sure whether I should be looking at SaMD differently compared to other medical devices?
Also, if we do not want to be legally responsible, wouldn't it be possible to just develop the software and hand it over?
 
Last edited:

dgrainger

Trusted Information Resource
#4
Manufacturer is defined:

(30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;​

You can only have one 'manufacturer' of a device, but you may have multiple manufacturers of components of that device.
 

yodon

Staff member
Super Moderator
#5
So my question was, is there any difference when it is not a usual medical device but an SaMD? Basically, am not sure whether I should be looking at SaMD differently compared to other medical devices?
SaMD *is* a medical device and must meet all relevant regulatory requirements. (Hint: ANSI/AAMI 62304 is a harmonized standard so complying with it gives you a presumption of conformity to the regulatory requirements in the EU.) There is one legal manufacturer (as @dgrainger reiterated). Whomever markets the software (and is thus accountable to the regulatory authorities) is the legal manufacturer. (Another hint: that company would be best off to have an ISO 13485 cert.)

Also, if we do not want to be legally responsible, wouldn't it be possible to just develop the software and hand it over?
Indeed, it's quite common for a legal manufacturer to outsource the software development effort. They should impose requirements on you to, say, develop in a manner compliant with 62304.
 
#6
SaMD *is* a medical device and must meet all relevant regulatory requirements. (Hint: ANSI/AAMI 62304 is a harmonized standard so complying with it gives you a presumption of conformity to the regulatory requirements in the EU.) There is one legal manufacturer (as @dgrainger reiterated). Whomever markets the software (and is thus accountable to the regulatory authorities) is the legal manufacturer. (Another hint: that company would be best off to have an ISO 13485 cert.)



Indeed, it's quite common for a legal manufacturer to outsource the software development effort. They should impose requirements on you to, say, develop in a manner compliant with 62304.
Thank you so much for the explanation.
Manufacturer is defined:

(30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;​

You can only have one 'manufacturer' of a device, but you may have multiple manufacturers of components of that device.
Manufacturer is defined:

(30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;​

You can only have one 'manufacturer' of a device, but you may have multiple manufacturers of components of that device.
Hi, so I went back and found the article which was the source of my confusion- the concept of multiple manufacturers for a product and realized they were talking about the case that involves a virtual manufacturer and an OBL manufacturer. In this case though the OBL manufacturer has all the regulatory responsibility, it is as if the product has more than one manufacturer (not the best way to put it but I at least understood what they meant) I hope this makes sense? Please correct me if am wrong.
 
#7
Ok,
SaMD *is* a medical device and must meet all relevant regulatory requirements. (Hint: ANSI/AAMI 62304 is a harmonized standard so complying with it gives you a presumption of conformity to the regulatory requirements in the EU.) There is one legal manufacturer (as @dgrainger reiterated). Whomever markets the software (and is thus accountable to the regulatory authorities) is the legal manufacturer. (Another hint: that company would be best off to have an ISO 13485 cert.)



Indeed, it's quite common for a legal manufacturer to outsource the software development effort. They should impose requirements on you to, say, develop in a manner compliant with 62304.
I think this answers my question quite clearly. Thank you!
 
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