Recommended EU 2017/745 electronic submission format

V

VJRill

Registered
#1
#1
Hi,
We have a legacy device which is CE mark under MDD 93/42/EEC. This submission was formatted to NB-MED/2.5.1/Rec5 using Part A and Part B recommended structure. We want to obtain the EU 2017/745 certification. Do we need to change our current structure for EU 2017/745 certification? It is easily read and updated to all of the requirements in EU 2017/745 Annex II and III.
Thank you,
 
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Philip B

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#4
#4
Is your NB BSi? If not, check with them regarding their submission preferences. Best to meet your NB requirements as closely as you can to make the whole painful process slightly less painful.
 
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