Hello,
We are an IVD company that is doing Virtual Manufacturing. We are now registering with EU from Ireland for CE Mark. Would we have to register under the old Directive MDD or the new IVDR Regulation (EU) 2017(746). I have downloaded the form and it only has option of selecting only Directive (IVD 98/79/EC) . Please guide us.
We are an IVD company that is doing Virtual Manufacturing. We are now registering with EU from Ireland for CE Mark. Would we have to register under the old Directive MDD or the new IVDR Regulation (EU) 2017(746). I have downloaded the form and it only has option of selecting only Directive (IVD 98/79/EC) . Please guide us.
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