Class I Medical Device Importing for OEM Requirements

[bikeshox]

Hi forum members,

There is an existing thread on this topic:

Medical Device (MedDev) Vigilance Guidelines for Importers into the UE

But it is a bit old and a little different...

We are a manufacturer of Class I medical devices based in the EU. We manufacture our own "branded" product, as well as "Private labels" for various distributors/(manufacturers), and sell to OEM customers where they kit our product into their product and call it their own.

We are looking to import a particular product from outside the EU and I am looking for information regarding the requirements of the exporter and for us, the importer.

We would buy the product from the exporter and resell the product to OEM customers which they would then place in a kit.

I hope that is enough information for someone to point me in the correct place! And in advance as always, Thanks!

 

[phloQS]

Dear bikeshox,

As I would guess, these products will also be class I -devices. Than you are responsible to have an own technical documentation for the products, like for all the other products you have "own branded". If your supplier already has CE-marked the products, you can make a QAA ( Qualityassurance agreement) which regulates that they have the technical docu and you get certificates etc. from them.

Regards

phloQS

 

[bikeshox]

I think what I am understanding is that somewhere in the supply chain someone needs to maintain the appropriate documentation for the device.

Depending on our potential customers, some of them might already have technical documentation for their completed product (or they might not depending on the quality agreements they use with their suppliers.)

If our customer is CE marking the final product with their name on it they need either the technical documentation themselves, or proof of the technical documentation being completed (Declaration of Conformity)

Am I close?

 

[phloQS]

Dear bikeshox,

You re very close! For class I devices the DOC might be enough. This depends on the authorities in each country. In Germany for example, there is nearly no surveillance of class one devices (non sterile) by the authorities. But if there are problems it would be better for the manufacturer to have at least a review of the technical documentation from a third party (For example a notified body). In this case it is very important to have a good quality assurance agreement which grants, that the manufacturer (on the label) gets the whole TD.

Regards

phloQS