Regulatory Open Forum

Hello,

I wonder what is the best way to establish conformity for control materials that need CE-marking under IVDD and IVDR.

As I understand it, under IVDD, control materials are classified as the "parent" IVD. How do I draw up the technical documentation as basis for the corresponding DoC? Do I need to draw up full documentation (STED) or are there ways to simplify?

Under IVDR basically the same question, although the classification is different. if the parent IVD is class C, the control material could still be classified as class A,B or C depending on the design/use of the control material. Do you have any suggestions/guidelines how to draw up the (a simplified?) technical documentation?

Thanks in advance.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Hello Enrico,

I would recommend reading through Annex VIII in the EU IVDR regulation as quite clear for controls such as Point 1.6 and Rule 7.  Basically for the classification controls if qualitative or quantitative take on class of analyte, otherwise defaults to Class B.  To answer your questions about Declaration of Conformity (DofC) and technical documentation this may depend on the assay, test, kit, etc., and how all the components are put together.  As an example, if the controls are used across multiple assays then maybe it needs a separate Tech Doc and DofC.  If only used with an assay or kit, then maybe it can all be in one Tech Doc and DofC.  The same holds true for documentation from an IVDD or IVDR perspective, but really should just be modifying, updating, or creating information to the EU IVDR.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Feb-2022 10:06
From: Enrico Schurig
Subject: Technical documentation for control materials

Hello,

I wonder what is the best way to establish conformity for control materials that need CE-marking under IVDD and IVDR.

As I understand it, under IVDD, control materials are classified as the "parent" IVD. How do I draw up the technical documentation as basis for the corresponding DoC? Do I need to draw up full documentation (STED) or are there ways to simplify?

Under IVDR basically the same question, although the classification is different. if the parent IVD is class C, the control material could still be classified as class A,B or C depending on the design/use of the control material. Do you have any suggestions/guidelines how to draw up the (a simplified?) technical documentation?

Thanks in advance.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Dear Richard,

I see, it is difficult to have a precise suggestion (even more with the limited information I gave). About classification it is pretty clear. How I draw up the technical documentation, I am still not clear about it. It's a control product for one specific analyte/IVD mainly used when local regulation requires the use of the control.

Thanks for your input.

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Original Message:
Sent: 17-Feb-2022 09:16
From: Richard Vincins
Subject: Technical documentation for control materials

Hello Enrico,

I would recommend reading through Annex VIII in the EU IVDR regulation as quite clear for controls such as Point 1.6 and Rule 7.  Basically for the classification controls if qualitative or quantitative take on class of analyte, otherwise defaults to Class B.  To answer your questions about Declaration of Conformity (DofC) and technical documentation this may depend on the assay, test, kit, etc., and how all the components are put together.  As an example, if the controls are used across multiple assays then maybe it needs a separate Tech Doc and DofC.  If only used with an assay or kit, then maybe it can all be in one Tech Doc and DofC.  The same holds true for documentation from an IVDD or IVDR perspective, but really should just be modifying, updating, or creating information to the EU IVDR.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 16-Feb-2022 10:06
From: Enrico Schurig
Subject: Technical documentation for control materials

Hello,

I wonder what is the best way to establish conformity for control materials that need CE-marking under IVDD and IVDR.

As I understand it, under IVDD, control materials are classified as the "parent" IVD. How do I draw up the technical documentation as basis for the corresponding DoC? Do I need to draw up full documentation (STED) or are there ways to simplify?

Under IVDR basically the same question, although the classification is different. if the parent IVD is class C, the control material could still be classified as class A,B or C depending on the design/use of the control material. Do you have any suggestions/guidelines how to draw up the (a simplified?) technical documentation?

Thanks in advance.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------