Hi, all.
I found "DECISION (EU) 2022/6".
Note) I'm sorry, but I just registered recently, so I can't seem to get the link yet. Please refer to this source by replacing "*****" in the following address with "https".
*****://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32022D0006#ntc5-L_2022001EN.01001101-E0005
According to the above sources, the harmonized standards such as EN ISO 13485:2019+A11:2021, EN ISO10993 series, EN ISO15223:2021 have been added to EU MDR.
By when do you need to comply with these harmonious standards?
Note 1: Our product is a class 1 device that does not require NB involvement.
Note 2: I asked the same question in another thread, but I moved the question because this thread seems to be more relevant.
Thank you.
I found "DECISION (EU) 2022/6".
Note) I'm sorry, but I just registered recently, so I can't seem to get the link yet. Please refer to this source by replacing "*****" in the following address with "https".
*****://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32022D0006#ntc5-L_2022001EN.01001101-E0005
According to the above sources, the harmonized standards such as EN ISO 13485:2019+A11:2021, EN ISO10993 series, EN ISO15223:2021 have been added to EU MDR.
By when do you need to comply with these harmonious standards?
Note 1: Our product is a class 1 device that does not require NB involvement.
Note 2: I asked the same question in another thread, but I moved the question because this thread seems to be more relevant.
Thank you.