Hi Gavin,
Article 4 of the MDD states:
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
Most European countries require labelling to be provided in their national language(s), however some countries have exceptions for professional use only devices.
With respect to electronic labelling, my current understanding is that, in general, electronic labelling is not accepted (without hardcopy labelling) in Europe, although I do not have much experience in this area, so perhaps someone else can provide more detail.
Hope this helps,
Liz
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Elizabeth Goldstein
Auckland
New Zealand
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Original Message:
Sent: 06-23-2015 13:25
From: Gavin O'Hara
Subject: EU ruling for translated IFU into member state (Sweden)
We design and manufacture class 1 devices and I was wondering if anyone knew the ruling regarding IFUs needing to be translated into the member state language (that we wish to sell). Is this mandatory for Sweden for example and does device classification matter, or is that moot. We were wondering if we could have a hard copy IFU with our product in English (within the product packaging) and an online version with all the native languages we currently sell to on our website.
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Gavin O'Hara
Aspen Medical Products
Irvine CA
United States
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