MDR Requirements for Samples

#1
Hello all.

We are a manufacturer of Class I medical devices.
We have all the technical documents and DoC, etc. prepared for our products.

One of our distributors in EU have asked about possibility of purchasing of samples to promote the devices.
We are looking to supply a smaller version of the original products so that end-customers can try out the product before deciding on a purchase.

In this case, would we have to fulfill all the MDR requirements for this sample, such as UDI requirements, Labelling requirements, technical documents, declaration of conformity, etc?
The only difference between the proposed sample version and the full version are the number of uses available within a unit, and they will be labelled as "Not for Resale".

Since the size/spec is different, would we have to approach this as a completely new SKU and do all the registrations?


Thanks for all the help!!
 
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EmiliaBedelia

Involved In Discussions
#2
If customers are using the sample device for a medical purpose, in the same way they'd use the full size device, it would still be considered a medical device and you have to do all the same activities. The intended purpose would not change, even if the "business intent" for the trial size is for the customer to decide whether to purchase the full size.
Note that MDR specifically uses phrases like "placing on the market" "making available on the market" "putting into service" - NOT "selling". It doesn't matter if the customer is not paying for the device.

The trial size would definitely require a new UDI (distinct from the full size package) because it is a distinct trade item. From a practical perspective, I don't know how you would control the product internally if you didn't have a new SKU for the package. IMO it would be most straightforward to just add it as an additional variant to your existing technical documentation.
 
#3
If customers are using the sample device for a medical purpose, in the same way they'd use the full size device, it would still be considered a medical device and you have to do all the same activities. The intended purpose would not change, even if the "business intent" for the trial size is for the customer to decide whether to purchase the full size.
Note that MDR specifically uses phrases like "placing on the market" "making available on the market" "putting into service" - NOT "selling". It doesn't matter if the customer is not paying for the device.

The trial size would definitely require a new UDI (distinct from the full size package) because it is a distinct trade item. From a practical perspective, I don't know how you would control the product internally if you didn't have a new SKU for the package. IMO it would be most straightforward to just add it as an additional variant to your existing technical documentation.
Thanks for sharing your opinion. I think your points make perfect sense, although it is the worst case scenario for me as I would have to revise all my documentations and prepare new packaging material with new UDI barcodes for a sample.
 

dgrainger

Trusted Information Resource
#5
Or Article 21.3?

3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the​
showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices​
are intended for presentation or demonstration purposes only and cannot be made available until they have been​
brought into compliance with this Regulation.​
 

EmiliaBedelia

Involved In Discussions
#6
Or Article 21.3?

3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the​
showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices​
are intended for presentation or demonstration purposes only and cannot be made available until they have been​
brought into compliance with this Regulation.​
If they are being used for demonstration only (ie, are not being used for a medical purpose) and if they remain in the control of the manufacturer (key phrase above: "cannot be made available"), this would work.
As the situation was originally described, it sounds like this is more of a "trial size" and not a "demonstration", however. I'm envisioning a 1-pack of a bandage, for example, instead of a 100-pack.
 
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