Pooja,
Per Annex I of EU MDD 13.1, "Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for
devices in Class I or IIa if they can be used safely without any such instructions.". However if your Class 1 is either a sterile or measuring device (or both), it may need a IFU.
Also, is product 2 always sold with product 1? Then, you may add a "Consult IFU" harmonized symbol that can direct user to Product 1's IFU. If they're sold separately, this linking will not make sense for every user.
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Vidya
USA
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Original Message:
Sent: 08-Aug-2019 08:58
From: Pooja Rathor
Subject: Labelling accessories
Hello,
We are in the process of making the Marketing material (IFU,labels,reference cards) for our products.
We have a Product 1 (a medical device system) and Product 2(accessory to the medical device system). This accessory will not have a IFU of its own as its use will be stated in Product 1's IFU. We are considering adding a symbol on the Product 2's Box which references the use of an IFU. If we add this symbol will we still need to put a reference sheet in the packaging of Product 2 which notes" Reference the systems ( Product 1 ) IFU"???
Product I will be classified as class IIa in EU and Product 2 will be classified as Class I .
Any suggestions on this would be helpful.
Thank you.
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United States
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