Dear Rabel,
Similarly in the US it depends on the product status. The rules are different if it is a regular medical device that will also be used with cadavers, a device not yet ready for clinical use that is being tested with cadavers, or a device intended for use with cadavers only.
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Anne LeBlanc
United States
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Original Message:
Sent: 21-Jul-2023 03:20
From: Christoph Kiesselbach
Subject: Primary & secondary labels including product inscription for products not for clinical use
Dear Rabel,
I am not sure if I am interpreting your question correctly, but at least for the EU I would say this depends on the intended use given by the manufacturer. If the product qualifies as a medical device, then the MDR Annex I requirements for labeling and required information apply. If not then at minimum the requriements of the general product safety directive 2001/95/EC and the respective national regulations are applicable. Depending on the product there may be additional legal requirements.
In short: To give a more detailed opinion more details on the products and their intended use would be required.
Best regards, Christoph
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Christoph Kiesselbach
Reutlingen
Germany
Original Message:
Sent: 19-Jul-2023 05:07
From: Rabel Talpur
Subject: Primary & secondary labels including product inscription for products not for clinical use
Dear Raps Community,
I am writing regarding the EU & FDA labeling requirement (Primary & secondary labels including product inscription) for the medical devices that are not for the clinical use and are the products used for Cadaver workshops.
Are there certain regulation in place for such medical products?
Looking forward for your valueable input.
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Rabel Talpur
Freiburg
Germany
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