1 / 11

CE Marking For In-Vitro Diagnostic Devices

Navigate CE compliance effortlessly in In-Vitro Diagnostics. Your key to regulatory success. Stay ahead in the US market.<br><br>

MavenUS
Download Presentation

CE Marking For In-Vitro Diagnostic Devices

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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-VitroDevicesandCEMarking 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. WhatareIn-VitroDiagnosticDevices? 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: 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. Performance Evaluation Report (PER) Quality Management System (QMS) Post-Market Surveillance (PMS) and Post-Market Performance Follow-Up (PMPF) UDI (Unique Device Identification) Technical Documentation Labeling and Instructions for Use Economic Operators Notified Body Interaction Transition Period 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.

  11. Contact Us https://mavenprofserv.us/ce-marking-for-in-vitro- diagnostic-devices/ md@mavenprofserv.us

More Related