CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing

V

vardag

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#1
#1
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.
 

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Watchcat

Watchcat

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#2
#2
I'm not sure I understand your situation. I'm not familiar with EU registration. I am familiar with CE certification, aka CE Marking.

Are you trying to register your company as an IVD manufacturer? Or are you trying to secure CE certification for one or more of your IVD products?
 
V

vardag

Registered
#3
#3
Watchcat said:
I'm not sure I understand your situation. I'm not familiar with EU registration. I am familiar with CE certification, aka CE Marking.

Are you trying to register your company as an IVD manufacturer? Or are you trying to secure CE certification for one or more of your IVD products?
Click to expand...
We are doing both but plz. give guidance on CE Mark
 
Watchcat

Watchcat

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#4
#4
Here are a couple of links that may help you:

Where are Notified Bodies with their application to the EU IVDR 2017/746?

EU IVDR Regulatory Changes: Overview of Requirements in 2017/746

As far as I know, no NB has yet been designated under the IVDR, so you still can't secure certifcates under the IVDR, only under the IVDD. When you do, you will want to be sure that you understand exactly what those certificates will allow you to do going forward. A lot of the MDD/MDR crowd is now in full panic, because only two NBs have been designated under the MDR and their critical dates are coming up much sooner than those for IVD manufacturers, and so far the EC is standing fast on its timelines. There are currently as many rumors as facts floating around the internet.

If you are going to try to DIY this, you are going to have to do a ton of reading, not just rely on guidance in forums like this. If RA isn't your primary area of expertise/responsibility, the DIY approach probably won't end well for your company. Sadly, things may not end well for a lot of companies, no matter what they do. No amount of expertise will get you a certificate if there are no NBs available to issue them.
 
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