New set of medical devices - samples

kormach

Starting to get Involved
Hello, maybe someone can clarify me the "samples" topic.

As a manufacturer we have a lot of interesting ideas for new devices. If the product is something new, but based on similar products on the market, we are sending the samples to our clients (doctors) to assess if the product is ok and will be useful in clinical conditions (they can perform some tests, but not on the patients). The samples are marked as "sample not for sale, only for testing". They do not have the CE mark, as they are before certification.

But sometimes we want to check if the new set of our devices will be interesting for the clients.
Example: We have 3 registered and certified devices: name1 (set: A, B, C), name2 (set: D, E, F), name3 (set: G, H, I) [all sets are for the same clinical condition and the set is only the recommendation for technique of work, so doctors can, for example, choose only A/B/C device or use A+B/A+B+C devices, depending on the clinical case]. From these three sets we would like to have a new set: name4 (set: B, E, I) - particular components from the set are already registered and certified but in different combinations and name. The intended use, patient population, medical condition, area of contact, user, environment are the same, only the technique of work is changing. Again, we want to check if the product will be suitable for our clients and send it to them. In this case they are know that it is a new combination of devices they are already using. So they will be checking the new set probably on the patient. How should we mark the samples? Still do not use the CE mark because the product is in this combination before certification?

I hope you understand my way of thinking :D if something is unclear, I can clarify.

Thank you for your response in advance :)
 

Billy Milly

Quite Involved in Discussions
Do you certify sets or individual components? Device is "legal" when it is fully CE marked (certified).
Use of "medical devices" without CE on patients is a direct violation of the applicable law and you are also legally responsible. The only exception is the clinical investigation with its own set of requirements.
 

kormach

Starting to get Involved
We certify type of product under one name (dozens of sizes and lengths) and we sell it as sets [name1 (set: A, B, C)] and refills [one package including only device A, B or C]
 

yodon

Leader
Super Moderator
We always have such samples marked clearly with "Not for human use" to help ensure these aren't used on / with patients. You could be pretty exposed.
 

DanMann

Quite Involved in Discussions
We certify type of product under one name (dozens of sizes and lengths) and we sell it as sets [name1 (set: A, B, C)] and refills [one package including only device A, B or C]
You could look into the concept of a procedure pack if the components are individually certified as medical devices.
 
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