• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—Feb. 4

    MO SCI Acquires Assets of 3M’s Advanced Materials Business

    Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets

    Aspivix's Carevix Cervical Stabilizer Gains FDA OK

    Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Fusion Biotec Inc.

    Medbio LLC

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    Medbio LLC

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Preparing for the EU’s MDR

    As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.

    Preparing for the EU’s MDR
    Related Content
    • Johari Digital Healthcare Ltd.
    • Providien
    • RJG
    • Zeus
    • Web Industries Inc.
    Nick Tippmann, Vice President of Marketing, Greenlight Guru04.29.21
    On May 26, Europe’s medical device regulation (EU MDR) will go into effect. With roughly 500,000 different medical devices currently sold in the EU, the impact of this update in the European marketplace is enormous in scale. Entities responsible for medical devices must conform to new, stricter requirements. But are these medical device companies prepared?
     
    According to Greenlight Guru’s recent 2021 EU MDR Preparedness Study, only 18 percent of medical device companies are ready for EU MDR. With such limited time left to prepare, this is alarming.
     
    The risk of noncompliance is costly and inefficient, but many organizations are lost on where to start. To help set them on the right path, our team has outlined key obstacles as well as a preparedness plan that identifies key areas where industry professionals can double down and close the gap for compliance before the deadline.
     
    What’s Standing in the Way?
    When speaking with medical device professionals about their challenges in preparing for EU MDR, three key issues surfaced: a lack of resources, planning, and guidance.
     
    Insufficient resources stood out among the rest as a top challenge—and the pandemic only exacerbated the issue. According to the Greenlight Guru 2021 medical device industry benchmark study fielded in October 2020, 63 percent of industry professionals feel the pandemic negatively affected funding at their organization, 39 percent found COVID-19 harming financial viability, and another 59 percent stated it had negatively affected time to market. With competing major concerns, it’s understandable a lack of resources is a core challenge for EU MDR preparedness.
     
    Close behind limited resources is a lack of planning. The unfortunate reality is that many medical device companies did not adequately prepare for EU MDR. According to report findings, 46 percent of industry professionals stated they were confused about the new requirements and what steps were needed to comply with the new regulation.
     
    Some industry organizations, like Medline Europe, had planned training courses to cover the EU MDR requirements and help overcome the lack of guidance. However, many of these courses were canceled due to COVID-19, leaving 32 percent of industry professionals feeling they lack the right expertise and processes to support transitioning to the new requirements set forth in the medical device regulation. To help supplement the lack of guidance, Greenlight Guru recently hosted a free, 5 day virtual summit focused on everything device and IVD makers need to know about the EU MDR and IVDR.
     
    Your Preparedness Plan to Ensure Readiness
    While organizations subject to EU MDR should be close to completion in terms of compliance, our research shows otherwise. With the transition period drawing to a close, there are some last minute preparedness activities medical device companies can start today to increase the likelihood of hitting the deadline.
     
    Internal Test-Run Audits
    Internal audits allow industry professionals to ensure they’ve accounted for all applicable medical device requirements. Some organizations may be counting on current certifications under MDD to delay their deadline, but they should still schedule mock audits and optimize based on the results.
     
    Cross-Functional Survey
    Ensuring compliance with EU MDR needs buy-in and collaboration between a variety of internal teams, including R&D, regulatory affairs, quality assurance, management, and other stakeholders involved throughout the supply chain. Soon, consider issuing an internal “health check” survey to outline what each department feels are the most imminent threats to compliance. From there, prioritize resources in this final stretch.
     
    Plan Beyond the Deadline
    Even if your company has secured more time with certifications under MDD or is on the final sprint to compliance, plan beyond the May 2021 deadline. Unforeseen delays and retroactive document review can bog down companies. One European trade group predicts that due to a high amount of expiring certificates in 2024, there could be an insufficient number of notified bodies, leading to a medical device shortage in the EU—a previously unforeseen delay.
     
    At this point, it’s no small feat to prepare for EU MDR. But, it’s not impossible. By mitigating key challenges and implementing the three recommendations from our preparedness plan, medical device companies can set themselves up for a successful transition to compliance with new regulation.
     

    Nick Tippmann is the vice president of marketing for Greenlight Guru, a medical device quality management software (MDQMS) that provides an industry-specific solution to help device makers around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Nick is lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, Nick co-founded and led a media and event production company that was later acquired.
    Suggested For You
    Johari Digital Healthcare Ltd. Johari Digital Healthcare Ltd.
    Providien Providien
    RJG RJG
    Zeus Zeus
    Web Industries Inc. Web Industries Inc.
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    Benchmark Benchmark
    WuXi AppTec Medical Device Testing WuXi AppTec Medical Device Testing
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Anjon Medical Technologies Anjon Medical Technologies
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Rootstock Software Rootstock Software
    Summit Medical, an Innovia Medical company Summit Medical, an Innovia Medical company
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.

    Related Buyers Guide Companies

    • Johari Digital Healthcare Ltd.

      ...
      Kamal Kumawat, Marketing Manager 12.06.22

    • Providien

      Providien

      ...
      Bonalyn Boyd, Marketing Manager 11.30.22

    • RJG

      RJG

      ...
      Kara Eskeli 11.21.22


    • Zeus

      Zeus

      ...
      Laura Bright, Ad Manager 11.18.22

    • Web Industries Inc.

      ...
      Blake Phillips, Marketing Specialst 11.18.22

    Loading, Please Wait..

    Trending
    • Study: Smartphone Therapeutic Helps Improve Fibromyalgia In Patients
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • Environmental Sustainability Becoming Increasingly Important To Medtech Industry
    • The Future Of Biomedical Engineering Advancements
    • A New Approach To Post-Market Surveillance
    Breaking News
    • MPO's Most-Read Stories This Week—Feb. 4
    • MO SCI Acquires Assets of 3M’s Advanced Materials Business
    • Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets
    • Aspivix's Carevix Cervical Stabilizer Gains FDA OK
    • Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    GOED Elects New Board Officers for 2023
    Aspire Hires Darrec Jones as VP of Business Development
    Pycnogenol Supplementation Linked to Better Hair Density in Menopausal Women
    Coatings World

    Latest Breaking News From Coatings World

    PPG Completes COLORFUL COMMUNITIES Project in Denmark
    10 Partners of the Automotive Industry Form JV, Cofinity-X
    BASF Recognized as Top Company for Supplier Diversity
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Feb. 4
    MO SCI Acquires Assets of 3M’s Advanced Materials Business
    Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Lilly 4Q Revenues Down 9% to $7.3B
    Bionova Expansion Project to Quadruple GMP Biologics Manufacturing Capacity
    Steriline Provides Fill-Finish Solution for Berkshire Sterile Manufacturing
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Pacifica Introduces Glow Baby Skincare Line
    Kohl’s Names Tom Kingsbury as Chief Executive Officer
    Mielle Unveils Haircare Bundles Inspired by Amazon Original Series Harlem
    Happi

    Latest Breaking News From Happi

    Grant Industries Names Mehran Ghadim Sales Manager, Canada
    Bio-Oil Celebrates Body Confidence Through Body Positivity Month Campaign
    Net Sales for Clorox Increase 1% for Q2 2023
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Pigments, Inkjet Ink Market Reports Top This Week’s Stories
    Roland DGA Announces Key Changes to Leadership Team
    Ball Reports 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    MM Packaging adds first Nilpeter press for Dublin site
    Polytag develops new UV tag reading technology
    Enterprise Print Group adds Screen Truepress Jet L350UV SAI E
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    What You’re Reading on Nonwovens-Industry.com
    Kimberly-Clark Supports Period Poverty Initiative in Australia
    Suominen Reports Q4, Full Year Results
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Feb. 4
    Toetal Solutions Secures $1.8 Million in New Financing
    Adrian Tyndall Joins Axogen's Board of Directors
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: CES 2023, ams OSRAM and Celanese Top This Week’s Stories
    Zebra Provides East West Shrine Bowl with RFID Tracking Technology
    AAAS Elects Three ORNL Scientists as Fellows

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login