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,
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,