Hi Everyone,
Can someone confirm that if it is a requirement to have your IFU in all 24 languages? Can we release the IFU only in languages of member states where the product is being sold? Is there a specific EU MDR requirement around this?
"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient."
It doesn't say that the device needs to be translated in all 24 languages? Is there a guidance or whitepaper released explaining this?
Can someone confirm that if it is a requirement to have your IFU in all 24 languages? Can we release the IFU only in languages of member states where the product is being sold? Is there a specific EU MDR requirement around this?
"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient."
It doesn't say that the device needs to be translated in all 24 languages? Is there a guidance or whitepaper released explaining this?