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On Flibusta and similar archives, she is primarily recognized for her biographical works and memoirs that preserve the legacy of her late husband and explore the "House on the Embankment" era. Key Works & Articles
Flibusta is a popular community-driven library for Russian-speaking readers. Users typically search for her there to find: of her out-of-print historical essays. On Flibusta and similar archives, she is primarily
: She has written extensively on the "Stalinist" period, often blending personal memory with archival research. Why look for her on Flibusta? : She has written extensively on the "Stalinist"
: As the director of this museum, many of her articles and publications focus on the history of the infamous building and the fates of its residents during the Great Purge. that provide a first-hand perspective on the "Thaw"
that provide a first-hand perspective on the "Thaw" and "Stagnation" periods of Soviet history.
Hello
We are company of medical device type II (sterelised needle) .Level of packagings are as following:
1 ) blister (direct packaging)
2) Dispenser 30 or 100 units
3) Shelf (about 1400 dispensers)
4) Shipper same as shelf (protective carton)
1)What is the alternative at blister packaging level , if we not indicate the manufacturer details : IFU, UDI etc is allow instead ?
2) same questions on Shipper level : what is the laternative ?
In Europe,US, Canada, turkie ?
3) What are the symbol that are mandatory according with packaging level?
Dear Nathalie,
the labeling on the sterile barrier system (SBS) – I assume in your case blister level, as these maintain the sterility of your device – is regulated either by the MDR (in Europe and also Türkiye) or by the recognized consensus standard ISO 11607-1 (EU, Türkiye, USA and Canada). In any case, the regulations require the manufacturer details directly on the SBS, there is no alternative.
Or are your devices not sold individually but only in the dispensers as the point of use? Then this dispenser could be considered as the outer protective packaging of your SBS and carry all required information.
The shipping packaging is only intended for transport and thus is not considered an additional packaging level, and as such is not required to fulfill any regulatory requirements. However, in certain cases (e.g. customs) a clear indication of the manufacturer is required to make the shipment traceable.
The information required on the packaging can be found in the MDR and 21 CFR part 801 as well as ISO 11607-1, the corresponding symbols in ISO 15223-1.
Let us know if we should discuss this in more detail in a short workshop, based specifically on your own device.
Kind regards
Christopher Seib