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 » EC Forms Expert Panels to Advise on MDR Implementation

EC Forms Expert Panels to Advise on MDR Implementation

June 27, 2019

The European Commission is creating expert panels to review the implementation process for the EU’s new medical device and in vitro diagnostics regulations after numerous industry groups have sounded alarms over the delay in implementing the new regulations.

With less than one year to go for devices to meet the May 26, 2020 implementation date — IVDs have until May 26, 2022 — the expert panels will assess high-risk devices and “contribute to the prospective improvement of the overall framework by advising the Commission, the Medical Device Coordination Group, Member States, notified bodies and manufacturers.”

The panels will also take on other tasks such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents and standards.  Experts on the panels will be appointed for three-year renewable terms.

View today's stories

Medical Devices Regulatory Affairs

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

  • FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

  • FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers

  • FDA Issues EUA for Monkeypox Vaccine

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • 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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing