CE Marking For In-Vitro Diagnostic Devices

1
CE Marking For In-Vitro Diagnostic Devices
www.mavenprofserv.us
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 conditi
on or a disease To determine the safety and comp
atibility 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
• Specimen Receptacle
• Accessory for an In Vitro Diagnostic Medical
  Device
• Device for Self-Testing
• Device for Near-Patient Testing
• Companion Diagnostic
• 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
• Classification
• Conformity Assessment
• Clinical Evidence

9

1. Performance Evaluation Report (PER)
2. Quality Management System (QMS)
3. Post-Market Surveillance (PMS) and Post-Market
   Performance Follow-Up (PMPF)
4. UDI (Unique Device Identification)
5. Technical Documentation
6. Labeling and Instructions for Use
7. Economic Operators
8. Notified Body Interaction
9. Transition Period
10. 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. Its
essential to stay informed about updates, seek
expert guidance, and engage with competent
authorities and notified bodies throughout the
regulatory journey.
11
Contact Us
https//mavenprofserv.us/ce-marking-for-in-vitro-
diagnostic-devices/
md_at_mavenprofserv.us