Hello,
Well there are only two Notified Bodies designated under the IVDR currently BSI UK and Dekra Germany. I personally have not heard if and when LNE GMed will be designated, so your decision might weigh on when you need to make the transition. In regard to selecting a new Notified Body, there are many factors that go into a decision, but an important aspect to remember is they will be a "life long partner" !
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Dec-2019 11:07
From: Julie Acker
Subject: IVDR Notified Body Search
Hello,
I would like to ask for customer feedback regarding LNE GMed as my firm must select a new notified body right away and have narrowed our selection down to LNE GMed and BSI. We have a very small number of IVD products that require Notified Body review.
Anonymous
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