I have been riddling this one out... and I have to admit I (with the help of a RA friend) have unoovered a means by which a LEGITIMATE organisation COULD secure a genuine IVD CE without a notified body.
It would not apply to a self test or a high risk IVD. And it would not apply to Genviro as a diagnostic device, because the stipulations around diagnostic capability would not be met!
But it seems it is possible for REPUTABLE IVD manufacturer to certify low risk IVD diagnostics for Professional ONLY use via a declaration of conformity route. Mea Culpe!
Does this mean Genviro has a route to a legitmiate CE mark? Absolutely not! The intent and effect of that statute is to prevent bureacracy from holding back improving or evolving IVD tests. It is not to allow fraudulent IVD devices to label themselves 'professional use only' as a back door to market entry.
The IVD 78/89 Annex III stipulations are very broad, and these easily capture the type of abuse that DECN or their partner MAY be trying to perpetrate here!
Essentially, the CE certification needs to include a full technical file, there has to be a named Authorized representative. And there has to be an ISO13485 standard QMS in place! And there are a great deal of other common sense requirements that Genviro is going to fall way short of!. Pedima/ DECN may THINK they CAN self certify for CE, by trying to exploit the 'professional use' exemption, but they are wrong. The circumstances and annex III requirements will mean that such any declaration so attempted WILL be fraudulent.
Nothwithstanding, I have contacted the BfarM and alerted them to the DECN back story. I am reasonably confident that at the first instance of any Genviro product actually appearing with a CE mark attached, they WILL pull the Technical file from the Authorised representative, and immediately act upon any deficiencies therein in short order. And there are going to be plenty! I will update you on their response when this is received!
News 
Market Data 
Discover 
AI
