1. CE Marking For In-Vitro
Diagnostic Devices
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2. Overview
In-Vitro Devices and CE Marking
What are In-Vitro Diagnostic Devices?
Critical points for CE marking of IVD devices under
the new IVDR
Conclusion
3. In-Vitro Devices and CE Marking
In the dynamic landscape of medical technology, the
regulatory framework plays a pivotal role in ensuring the
safety and efficacy of diagnostic devices. Particularly, the
CE marking process stands as a beacon for manufacturers
of in vitro diagnostic devices (IVDs), indicating compliance
with European Union (EU) regulations. As the demand for
cutting-edge diagnostic solutions continues to surge,
understanding the intricacies of CE marking for in vitro
diagnostic devices becomes imperative.
4. Within the realm of in vitro diagnostic test kits, the
significance of CE marking is particularly pronounced.
These kits, designed for rapid and accurate diagnosis of
various medical conditions, must undergo meticulous
scrutiny to meet the rigorous standards imposed by
regulatory bodies. The process of obtaining CE marking
involves a comprehensive evaluation of the design,
manufacturing processes, and performance
characteristics of in vitro diagnostic test kits.
5. What are In-Vitro Diagnostic Devices?
As per Article 2 of REGULATION (EU) 2017/746 OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL (IVDR), an
In- Vitro Diagnostic Device (IVD) can be defined as
Any medical device which is a reagent, reagent product,
calibrator, control material, kit, instrument, apparatus,
piece of equipment, software or system, whether used
alone or in combination, intended by the manufacturer to
be used in vitro for the examination of specimens,
including blood and tissue
6. donations, derived from the human body, solely or principally for
the purpose of providing information on one or more of the
following:
Concerning a physiological or pathological process or state;
Concerning congenital physical or mental impairments;
Concerning the predisposition to a medical condition or a
disease;
To determine the safety and compatibility with potential
recipients;
To predict treatment response or reactions;
To define or monitoring therapeutic measures.
7. Apart from the devices covered in the above definition, In-
Vitro Diagnostic Devices (IVDs) can also be made available
in various types that may include but not be limited to the
following:
1.Specimen Receptacle
2.Accessory for an In Vitro Diagnostic Medical Device
3.Device for Self-Testing
4. Device for Near-Patient Testing
5.Companion Diagnostic
6.Generic Device Group
8. Critical points for CE marking of IVD
devices under the new IVDR
The CE marking process for in vitro diagnostic test kits
under the new In Vitro Diagnostic Regulation (IVDR)
involves several critical points to ensure compliance with
the regulatory requirements. Here are key considerations:
1.Classification
2.Conformity Assessment
3.Clinical Evidence
9. 4. Performance Evaluation Report (PER)
5.Quality Management System (QMS)
6.Post-Market Surveillance (PMS) and Post-Market
Performance Follow-Up (PMPF)
7.UDI (Unique Device Identification)
8. Technical Documentation
9.Labeling and Instructions for Use
10.Economic Operators
11.Notified Body Interaction
12.Transition Period
13.Training and Competence
10. Conclusion
Adherence to these critical points will contribute to a
successful CE marking process for IVD devices under the
new IVDR. It’s essential to stay informed about updates,
seek expert guidance, and engage with competent
authorities and notified bodies throughout the regulatory
journey.
