Shirley,
The EU MDD and EU MDR are quite clear about the CE Mark representing the device. If the device is single-use only, it does not need to be on the device itself. Though it needs to be on the primary packaging of the (sterile) single-use device. If the primary packaging is too small, then there should be secondary packaging which has not only the CE Mark, but all of the appropriate product identification as well.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Sep-2023 03:10
From: Stephane Mazet
Subject: CE marking of conformity
Hi Shirley,
MDD articles 17.1 and 17.2 clearly state that the CE mark need to appear on the device. A deviation for small-scale devices is that the dimension can be less than 5mm per Annex XII. Maybe if your device is too small for the CE mark to be legible, you could justify to have it on the packaging and IFU.
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Stephane Mazet
Paris
France
Original Message:
Sent: 05-Sep-2023 13:57
From: Shirley Kadouri
Subject: CE marking of conformity
Does anyone have creative arguments to support the claim that CE marking of conformity only on the IFU & sales packaging but neither on the device or its sterile pack, is still a compliant configuration (as per MDD Article 17 (3))?
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Shirley
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