Technical documentation for IVDD General/ other

Eddie Wong

Registered
Hi everyone. We have a nucleic acid extraction instrument and wanna get it CE-marked.
I've been reading Annex III to 98/79/EC and I fail to understand the exact technical files required for CE-marking...
Has there anyone had similar registration experience?
Anyone could advise me on what guidance I should look up to?
Appreciated!
 

chris1price

Trusted Information Resource
98/79/EC Annex III is pretty straight forward, section 3 lists all the documentation you need to compile. I would set up a file with headings matching the bullets then fill in the information. If you don't have what is requested, then you need to start doing the necessary work.

However..... you are less then 12 months away from the new IVD regulation. This will almost certainly require review of your files by a notified body. I would strongly recommend working towards meeting that regulation rather than the IVDD.
 

Eddie Wong

Registered
98/79/EC Annex III is pretty straight forward, section 3 lists all the documentation you need to compile. I would set up a file with headings matching the bullets then fill in the information. If you don't have what is requested, then you need to start doing the necessary work.

However..... you are less then 12 months away from the new IVD regulation. This will almost certainly require review of your files by a notified body. I would strongly recommend working towards meeting that regulation rather than the IVDD.
Thanks Mr.Chris Price. The instrument falls into Class A under IVDR so no NB would be involved.
So I will just compile technical files and a DoC and send them to European Representative then I can affix a CE mark, right?
 

chris1price

Trusted Information Resource
Essentially, you are correct, for a class A product you complete the technical documentation and CE Mark your device. However, take a look at Annex II and III of the IVDR, there are a lot of requirements there, it is much more than needed for IVDD. I also suggest including a good rationale for why your device does not fall under Rule 3i as a device for genetic testing and be Class C.
 
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