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 » Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe

Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe

June 15, 2018

One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.

Although IVDs have until May 2022 to transition from being CE marked under current regulations to being CE marked under the new regulations, the transition is likely to be further drawn out for IVDs that need to be certified by a notified body, the industry association noted.

“Regulatory documentation — such as Declarations of Conformity, certificates, labels and instruction for use — issued under the current Directive, may remain valid until up to approximately May 2024, and can both continue to be used and will lawfully remain in circulation,” Medtech Europe said in a new paper on the transition process.

IVDs that are not supervised by notified bodies will need to comply from May 26, 2022 onward to be marketed in the EU. The association stressed that the new regulations for devices and IVDs add complexity and secondary legislation is needed to address how some key provisions will work.

View today's stories

Medical Devices Regulatory Affairs

Upcoming Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

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

  • Okami Medical’s LOBO-7 and LOBO-9 Vascular Occluders Cleared

  • FDA Puts Clinical Hold on Astellas Late-Onset Pompe Disease Clinical Trial

  • FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

  • Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

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