Regarding design and development requirements for a medical device

#1
Let's say that for a medical device that I want to put in the EU market I will buy the parts A and B outside the EU market, and attach them together to make my final medical device (basically the parts would be purchased according to specifications and only a simple assembly would be done in a EU country).

Would this be considered manufacturing a medical device, considering I'd be purchasing parts A and B already finished and only putting them together? (they dont' work independently)

What would the design and development requirements look like in said product, provided the original design for the product would not be mine? Could the company producing parts A and B be classified as a supplier (they manufacture these parts for other companies in other non-eu countries)?

I was expecting that I'd have to specify design and development for the final product, including specifications for the parts A and B to which the supplier would have to comply, but don't know how it would be possible to comply with design and development for each part (since I don't have access to that data).
Thank you
 
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#3
You might want to take a look at EUMDR article 22. With the information presented, it sounds like you might have a "procedure pack":
Thank you for your reply. I'm aware of the different definitions, but I don't think systems and procedure packs apply because neither part A or B are a medical device of their own or are CE marked. I could be wrong though.

I can give the example of an eletrical toothbrush to try to clarify further what I meant: combine the motor part and the brush part to make the final product. A company overseas produces both parts, but lets imagine a toothbrush in EU would be a medical device and in the other countries it wouldnt. I'd be buying the motor part and the brush part and assemblying them in EU. It's more or less what would happen in this case.
 

EmiliaBedelia

Involved In Discussions
#4
You might want to take a look at EUMDR article 22. With the information presented, it sounds like you might have a "procedure pack": EUR-Lex - 02017R0745-20200424 - EN - EUR-Lex
It's not a procedure pack because the manufacturer is assembling the components together to create a device. A procedure pack is individual devices that are all used in one procedure packaged together. If the electric toothbrush and a floss pick were being packaged together then... maybe. TBH I think these situations add a lot of complexity so if you don't strictly have to be a procedure pack/system I would not suggest it.

Would this be considered manufacturing a medical device, considering I'd be purchasing parts A and B already finished and only putting them together?
Yes, you are manufacturing a device. Many, many manufacturers do not make devices in house and only assemble purchased components.
For design and development, you need to specify what the requirements are for the components and how you know that the components you selected meet those requirements. You would need some kind of verification testing to show that your assembled device meets the requirements you have set out. Even if you are not specifying all the details of HOW exactly it is designed, you need to empirically show that it meets your requirements in the context of YOUR intended use.

To continue in your example, let's say you have decided you want to manufacture a toothbrush for adults. Your (overly simplified) requirements are: brush head of 1 cm, 100 oscillations per second, materials are biocompatible, device lifetime is 5 years using it 2x/day, meets electrical safety requirements. None of those specifications would require detailed information about the design/development. Your job is to explain how you came up with those requirements, and show through V&V that the components (Brush Head A and Motor B) meet your specs.

The company producing parts A and B is, by definition, a supplier, if you are purchasing the parts from them. Reference ISO 13485 and MDR article 10 point 9(d) and point 15 for more information on supplier controls and purchasing - if someone else is making stuff for you, you need to do some due diligence to ensure that the supplier is good, and that the materials they provide to you meet your requirements for performance and for safety/quality. FWIW, if you are going to be working with a supplier to make medical device components, they will probably need to provide you with more information than they might generally provide for non medical applications. This is a part of supplier controls - if the supplier is not willing to cooperate with you and provide the information you need, they are not a suitable supplier (or, you need to figure out another way to sufficiently control their activity).
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#5
I agree with Emelia. It also depends on your claims. After you combine these parts, what are you claiming it can do?
 
#6
All these replies are very very helpful, thank you Emilia and Ed. What Emilia set out in a very simplified manner is thankfully what was already planned. Find a suitable supplier that would be willing to cooperate with the needed information, and through validation and verification show that the requirements for the device and its intended use are met, even if the design part is not exactly specified (as I don't have the design details for those parts)

So basically I'd have to set out supplier controls for the parts, and then the design requirements would relate obviously to each part to confirm that they do meet the requirements I've set out, and to the claims established to what the final device can do.
 

Zero_yield

"You can observe a lot by just watching."
#7
Yup, thanks for the correction, Emilia. I honed in on the "I'd be purchasing parts A and B already finished and only putting them together" and missed the part about assembly. I was incorrectly thinking you'd just be putting them in a combo pack together (i.e., here's a needle AND the correct tubing to go with it).
 
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