Anon,
No there is no requirement for this and in most cases the users probably would not know if the product was EU IVDD versus EU IVDR. This would be detailed and designated in the Declaration of Conformity identifying which Directive/Regulation applies - if the user even looks at this detail.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 28-Sep-2023 08:44
From: Christoph Kiesselbach
Subject: Do users have to buy IVDR CE-marked over IVDD CE-marked?
Hi Anon,
As far as I can tell as long as IVDD devices fulfill the requirements for legacy devices according to Article 110 of the IVDR, they may be placed on the Union market and there is no restriction for users or obligation to prefer an IVDR device. Even the limitation on in-house devices with respect to a justification will only be applicable from 26 May 2028 (see IVDR Article 113(j)).
Best regards
Christoph
------------------------------
Christoph Kiesselbach
Reutlingen
Germany
Original Message:
Sent: 27-Sep-2023 12:04
From: Anonymous Member
Subject: Do users have to buy IVDR CE-marked over IVDD CE-marked?
This message was posted by a user wishing to remain anonymous
Hello Everyone,
Do EU users have to buy a product that is CE-marked to the IVDR if a similar product (i.e., same intended use) is available but is still being distributed under the IVDD transitional provisions with a CE-mark?
I've read though the IVDR and I only see that Health Institutions must buy IVDR products over in-house developed tests, or they must provide justification of in-house use over IVDR CE-marked. But this doesn't seem to apply to the general market. Can someone please confirm?
Thank you