We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Medical Devices » Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules

Other Options

PDF Edition

$397.00

PDF Edition - 3-4 Copies (10% Off)

$357.00

PDF Edition - 5-6 Copies (15% Off)

$337.00

PDF Edition - 7-9 Copies (20% Off)

$317.00

PDF Edition - 10+ Copies (25% Off)

$297.00
Clinical and Performance Evaluation Under EU-MDR

Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules

$397.00
Medical Devices

Product Details

The impending EU Medical Device Regulation (EU-MDR) and its companion In Vitro Diagnostic Regulation (IVDR) are raising the bar for demonstrating the safety and performance to obtain or maintain the critical CE mark necessary to market products in the EU. 

Notified bodies (NB) are now more strictly enforcing clinical and performance evaluation requirements. You must learn how to prepare the strongest — most convincing — clinical evaluation and performance evaluation reports for your CE mark submissions.

Many device and diagnostics companies are performing these evaluations for the first time or are struggling to understand the NBs’ raised expectations

Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules outlines the new requirements and provides details on how to perform the necessary evaluations and prepare the resulting reports. It describes common pitfalls companies face in making their case to NBs and offers recommendations for sidestepping them.

You will learn about the three pillars of performance evaluation, the level or clinical evidence required for a CE mark, how clinical evaluations can be leveraged to produce stronger performance evaluation reports, how to conduct postmarket clinical follow-ups and more.

Management Report Takeaways Include:

  • EU-MDR requirements for clinical evaluations and IVDR requirements for performance evaluations, including what plans and reports are needed for these evaluations
  • Ideas for the recommended structure of the reports, such as what sections are required for each type of evaluation and the type of data that goes in each section
  • How literature searches can be used within these evaluations
  • Strategies for overcoming common NB findings and pitfalls, including properly justifying equivalence and data presentation

Clinical and Performance Evaluation Under EU-MDR will guide you to a deeper understanding of what your company must do to meet the EU-MDR and EU-IVDR requirements and how to manage any necessary adjustments.

Ensure your CE mark success. Order your copy today.

Who Will Benefit

  • Quality manager
  • Regulatory manager
  • Submissions manager
  • Design manager
  • Technical manager
  • Clinical manager
  • Authorized representative in Europe

PDF

$397.00
Add to Cart

ISBN-13:
978-1-60430-142-7

Publication date:
July 2020

Page count:
418


Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.


Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing