In my own personal experience, our Notified Body wanted to have the CE Mark directly on the vial label. Mostly because of the instances where we had "kits" with multiple vials or containers with reagents and while the box had the CE Mark, they wanted us to have the actual CE Mark on the vials as well. Their reasoning was the vials or containers may all be taken out of the box/carton and we still need to show identification of the device according to the IVDD (and in the future the EU IVDR). There were a couple instances where we got exception because the vial was just too small that already with the product name, part number, and lot number, there was virtually no space or the CE Mark would not have meet the minimum requirements for scale. Therefore, they gave us the exception. So as a general rule from my experience, you would try at all means to have the CE Mark directly on the vial label, barring any limitations due to space.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jan-2020 02:10
From: Kees Maquelin
Subject: IVD vial label CE marking
Hi Sanja,
Per Article 18.3 of the IVDR the CE mark on the vial (if it fulfills the definition of an IVD) is required. Justified exceptions are possible as you can see.
Article 18.3 reads:
The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.
Regards,
Kees
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Kees Maquelin
PhD, BSc
Netherlands
Original Message:
Sent: 21-Jan-2020 15:56
From: Sanja Matern
Subject: IVD vial label CE marking
Dear colleagues
Question related to the IVD products. Does your notified body require that your products have CE mark on the vial label in terms of satisfying the requirements of IVDD? I have seen different approches by different NBs. Is this a requirement in IVDR? Of course, CE mark on the box label is mandatory. Please share your experience. Thanks.
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Sanja Matern PhD
Regulatory Affairs Manager
Germany
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