Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

What should I as a regulatory professional think when reading several companies CE marking their products after just 1-2 months development? In Europe there is no open fast track authorization to expedite the CE marking so all requirements for stability and analytical and clinical performance evaluation apply. I've done CE marking quite a long time and my opinion here is that there is no way to release a safe and effective product within this time frame. I mean this is high risk product requiring a very thorough clinical performance evaluation which cannot be completed this quickly.

The other story is about releasing products with RUO status and selling these products to clinical laboratories. Even advertising products with RUO status for diagnostic use. At least in my country this is strictly forbidden. It's of course completely different story if the product with RUO status has passed fast track authorization in some territory (US, China) but this doesn't seem to be the case. For me it has been always obvious that there is no such thing than product with RUO status used for clinical diagnostics.

I'm eagerly waiting for your opinions. Thank you in advance.

This message was posted by a user wishing to remain anonymous

Hi, 

I think I may have found a resource that may make the EU's position regarding recent CE marking of tests clearer at the link below. They do make it clear that they have identified devices with fraudulent documentation, incomplete technical files or unsubstantiated claims and some the rapid test devices were being sold as self- tests in some member states.  For compliant CE-marked rapid diagnostic tests, they seem to acknowledge that the performance may vary in the routine testing laboratory vs the studies done by the manufacturer done for the purposes of CE-marking. They encourage clinical validation with a gold standard with a large number of target population subjects or even a second confirmation through a routine lab test. 
https://www.ecdc.europa.eu/sites/default/files/documents/Overview-rapid-test-situation-for-COVID-19-diagnosis-EU-EEA.pdf
Probably not the exact response you may be looking but hopefully this helps.
Original Message:
Sent: 25-Feb-2020 01:06
From: Anonymous Member
Subject: Coronavirus COVID-19 Diagnostics

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

What should I as a regulatory professional think when reading several companies CE marking their products after just 1-2 months development? In Europe there is no open fast track authorization to expedite the CE marking so all requirements for stability and analytical and clinical performance evaluation apply. I've done CE marking quite a long time and my opinion here is that there is no way to release a safe and effective product within this time frame. I mean this is high risk product requiring a very thorough clinical performance evaluation which cannot be completed this quickly.

The other story is about releasing products with RUO status and selling these products to clinical laboratories. Even advertising products with RUO status for diagnostic use. At least in my country this is strictly forbidden. It's of course completely different story if the product with RUO status has passed fast track authorization in some territory (US, China) but this doesn't seem to be the case. For me it has been always obvious that there is no such thing than product with RUO status used for clinical diagnostics.

I'm eagerly waiting for your opinions. Thank you in advance.

You should probably think the same thing I've been thinking about the EUA process in the US.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 25-Feb-2020 01:06
From: Anonymous Member
Subject: Coronavirus COVID-19 Diagnostics

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

What should I as a regulatory professional think when reading several companies CE marking their products after just 1-2 months development? In Europe there is no open fast track authorization to expedite the CE marking so all requirements for stability and analytical and clinical performance evaluation apply. I've done CE marking quite a long time and my opinion here is that there is no way to release a safe and effective product within this time frame. I mean this is high risk product requiring a very thorough clinical performance evaluation which cannot be completed this quickly.

The other story is about releasing products with RUO status and selling these products to clinical laboratories. Even advertising products with RUO status for diagnostic use. At least in my country this is strictly forbidden. It's of course completely different story if the product with RUO status has passed fast track authorization in some territory (US, China) but this doesn't seem to be the case. For me it has been always obvious that there is no such thing than product with RUO status used for clinical diagnostics.

I'm eagerly waiting for your opinions. Thank you in advance.