Hi,
I'm reaching out to better understand the following definition in the MDR requirement:
"The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile." [Annex I Chapter II paragraph 11.8 pg.98]
What I'm confused about is the pat of the definition saying: "additional to the symbol used to indicate that devices are sterile" - what does it means? do I put two contradicting symbols in one label? It make no sense.
I'm reaching out to better understand the following definition in the MDR requirement:
"The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile." [Annex I Chapter II paragraph 11.8 pg.98]
What I'm confused about is the pat of the definition saying: "additional to the symbol used to indicate that devices are sterile" - what does it means? do I put two contradicting symbols in one label? It make no sense.