Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1

Kuldeep Singh

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#1
Hello Everyone,

We are plan to provide the IFU in electronic form as well as paper form for our Class IIb X-Ray medical device. So please guide me applicable Articles of eIFU Directive EU 207/2012 to us. Is this directive only applicable to manufacturers which intended to provide their IFU in electronic form only?

As i read the directive and come to know that only Article 9 applicable to us. Rest of articles applicable to manufactures which provide the IFU in electronic form only.

Please guide me if i am wrong.
 
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