Joachim Reinke The lean approach would be to translate the "instructions for use" and the "accompanying documents" (I guesson that is what you mean by "product documentation"? - Because "product documentation" is not a defined technical term in the process of bringing medical products to market) at that point of time where you decide on the market entry into a particular country. I don't see any necessity to do costly translation work without a cause. Or am I missing your point?

Barb Sichel I agree. No one wants to pay for translations they don't need.

From a planning perspective, however, we often find translations treated as an afterthought. Thus, there are issues with timing and budget that could be avoided if this important step is incorporated into the overall product plan.

In country translations are costly and if market demand does not justify or demonstrate ROI, then they will follow the development.

They often also take significant time and so appear to lag on release but actually may have commenced much sooner in the cycle.

Marcus Gould Hi Barb. When looking at translations for placing on the European Union, you need to consider 1) the EU member state/EEA country you wish to place your device, 2) the class, and type of the device and so the registration requirements of the competent authority within the member state/EEA country; 3) its intended use and clinical setting and 4) size and scope of labels and labelling.

All of these need to be considered as part of the regulatory strategy so that costs and logistics of not only meeting Article 4 (4) and Essential Requirement 13 of the MDD is met, but that registration with the competent authority, if required, can be ensured and maintained.

Manufacturers often consider and solely focus on the translations of labels and labelling, but overlook the translation of documents which may be required for registering with the required competent authorities and/or customs authorities.

Marcus

On the projects I've worked in this far, choosing the market for eu products happens relatively early, and 14 languages seems standard for our labeling. This includes tyvek lids on disposables, ifu and shelf cartons. These are all pretty long lead time for us so it pays to get them done early.

And to ship test with that big IFU, it can break things in transit!

Our regulatory documents use the same translation houses but I'm not as familiar with the fine points

Nebrido Santiago Hi Barb,

While I agree with Marcus that it should be part of the overall regulatory strategy but at the same time it should be ideally included in the device risk management process bear in mind that this is important part of CE marking.
I believe RM is useful specially on the question of how far or extent you will going to translate your product information.
One can argue therefore that consider translation as part of the device life-cycle.