Hello Anon,
As others have mentioned, the device would be put into service regardless of any financial considerations - sales evaluations often can be used with patients, so needs to be treated as a legally marketed device.
Registration in a country of the European Union can be challenging, because there are still some countries which require this process. You would have to look at the local country to understand any registration requirements. The CE Mark has been intended for many years creating a "free market" but this really has yet to fully happen. There is also registration in EUDAMED which is currently not mandatory, but highly encouraged. If the company is OUS, you would also need an Authorised Representative (EU AR) - many of the questions you have should be able to be answered by your EU AR.
Translation is tricky subject because the simple answer is yes - it needs to be translated into the local language regardless of placing 1 unit or a thousand units. In fact, the European Commission recently released the informatic document concerning translation. If it truly is only one product, maybe you can get an agreement between the company and the physician in providing the Instructions for Use (IFU) and any other information in English only; might help but only lowers the risk of regulatory compliance. Product name and addresses on labels do not need to be translated.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 11-Apr-2024 02:25
From: Ronald Boumans
Subject: MDR Registration/Translation
Definition 2(27) is relevant here: 'making available on the market' means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
As long as this device is not used on patients, the MDR does not apply and thereby the language requirements do not apply. But if that physician uses it on a patient, all of the requirements must be met.
From a strategic point of view: what do you do if that physician says: 'Great, I'll order a bunch!'? Just translate the IFU now. If you do that in a smart way, it will take just a few days to get this done properly. As long as the document meets the requirements of Annex I, Section 23, it is fine.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 10-Apr-2024 06:45
From: Anonymous Member
Subject: MDR Registration/Translation
This message was posted by a user wishing to remain anonymous
Our device is CE marked but is currently only available in English. We do not have a presence in the EU but are trying to establish a market. We have the opportunity to place one device in one hospital for one doctor to use (note: does not qualify as a custom device). It is not a sale. It is a sales evaluation only. We will be providing the device IFU in the national language (non-English).
Two questions: 1. Do we really need to register the device in that country? At this time, pending the result of the sales evaluation, we do not know if there is a future market. 2. If we do need to register, is it necessary to provide the labels (package and product) in the national language? The only item on the label requiring translation is the product name and the Auth Rep address.
Certainly, if there is a successful sales evaluation, we will provide the appropriate labels and will register the product.
What are the risks of not registering or not providing a translated label for this single device placement?