• 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
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    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—March 25

    Getinge iCast Receives FDA Premarket Approval

    Tessy Plastics Corp. Celebrates 50th Anniversary

    Carium Expands Customization Options with Care Pathways

    InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    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
    Medbio LLC

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The

    LEMO USA Inc.

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The

    LEMO 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
    Columns

    Tips for Reigniting Your MDR/IVDR Preparation

    To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.

    Tips for Reigniting Your MDR/IVDR Preparation
    Image courtesy of Cannon Quality Group LLC.
    Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC02.03.21
    The COVID-19 pandemic clearly dropped a wrench in the gears of many industries as well as the normal routines of people across the globe. Through most of 2020, organizations scrambled to revise business strategies and processes to remain operational—and six feet apart—during the unique circumstances. It was a pivotal year for medical device companies that were busily preparing for the Medical Device Regulation (MDR)/In Vitro Device Regulation (IVDR), which was fast approaching. Then, in an 11th-hour decision, the industry received a welcome respite when the deadline was pushed out to May 26, 2021.

    Medical device manufacturers no doubt enjoyed having a breather to focus on more pressing issues. Stalled clinical trials, disrupted supply chains, and halted manufacturing lines have been common scenarios due to the pandemic. Nevertheless, several months of the moratorium have passed, and now, the task of preparing for the European Union’s (EU) regulatory upgrade is back on their plates.

    Restarting an already arduous project mid-stream can be daunting. Still, the clock is ticking again, and it’s time to dust off transition plans and get moving. To get the MDR/IVDR preparation ball rolling again, following are four processes to help refocus on achieving compliance with the updated MDR/IVDR Regulations.

    #1: Communicate
    What has changed? What changes are considered significant?

    Open channels of communication with your peers and colleagues—they are your allies. Over the course of the delay, changes most likely occurred in some aspects of your product or organization. In your conversations, identify what has changed and determine what the significant changes are that need to be readdressed in the plan. The more you can create some dialog around what significant change means, the better the whole organization will be at making the changes together.

    Some questions to bring up might include:
    • Are the business and product strategies still applicable, or have they changed in a way that will impact  compliance with MDR/IVDR?
    • Are the distributors and economic operators you were planning to work with in Europe still available? What is their transition status, and what are their plans for the future?
    • There are emergency use authorization (EUA) plans in the U.S. that a lot of medtech companies pivoted to support. Will those be launched in Europe as well?

    For instance, some changes considered significant are outlined in the Medical Device Coordination Group Document (MDCG) 2020-3 under Article 120(3). It’s a good idea to download and study this document. Also, consult with your Notified Body about the guidance because the agency’s opinion may differ from yours.

    Other changes that can impact strategy are outlined in the IAF Mandatory Documents (IAF MD) 9:2017, Section 9.6, which include:
    • A change in company ownership
    • Extension to manufacturing and/or design control—which now includes figuring out how to make room for social distancing
    • Modification of the site operation involved in the manufacturing activity, such as relocation of the manufacturing operation to a new site or centralizing the design and/or development functions for several manufacturing sites
    • Modifications to special processes, such as a change in production from sterilization through a supplier to an on-site facility, or a change in the sterilization method
    • Change in the defined authority of the management representative that impacts the quality management system effectiveness, regulatory compliance, or the capability and authority to ensure only safe and effective medical devices are released
    Again, it’s a good idea to review this document as you identify the changes relevant to your organization.

    #2: Revisit Your Transition Plan
    What is still applicable? What needs updating?

    If you had a plan in place prior to the delay, putting it back into action doesn’t need to be overwhelming. In addition to communication and identifying changes, it’s important to get reacquainted with the MDR/IVDR transition timelines:
    • May 26, 2021: The new deadline for compliance with MDR. Legacy devices must have an up-to-date MDR/IVDR CE mark from a qualified Notified Body to stay on the market. Manufacturers of medical devices cannot apply for MDR/IVDR re-certification of these products after this deadline.
    • May 2022: The deadline for compliance to IVDR. The timeline for IVDR did not change. The only shift was MDR. This results in a one-year difference between MDR and IVDR. Now that these dates are closer together, it will put more strain on the already overworked Notified Bodies. The pandemic put more stress on them just like it did on companies. That being the case, in-vitro device developers should begin preparing for the May 26, 2022, deadline by observing the efforts of companies that have transitioned to MDR or are still transitioning.
    • May 26, 2024: The end of the grace period extended to specified products with a valid certificate issued under the Medical Device Directive (MDD) prior to May 2021.
    • May 27, 2025: The end of availability or putting into service devices covered by MDD and Active Implantable Medical Devices Directive (AIMDD) certificates.
    Medical device functionality continues to evolve and become more sophisticated. In reviewing transition plans, organizations determine how they can make the necessary modifications as well as the arrangements to work with external entities in time for the new deadline.

    #3: Start Piloting
    “The way to get started is to quit talking and begin doing.” — Walt Disney

    Starting the transition process is challenging—especially when there still might be questions and uncertainties about the new regulations that were unresolved before the pandemic. One approach to make the tasks less overwhelming is to start blocking time to work on your plan. Look ahead a week, two weeks, or a month. However full your calendar is, block off some time for MDR/IVDR transition preparation.

    The following starting points can help decide how much time to plan for:
    • Start with products highest in revenue or are 80 percent likely not to change.
    • Start with what will be due on the May 2021 deadline.
    • Create a list of the items most volatile to change. Set this list aside to address at a later time when you’ve made some decisions and are more certain about the changes you will implement.
    • Start laying the groundwork for new products. Talk with your development teams, and identify the new pieces they should be integrating right now that will be necessary for complying with the new regulations.
    #4: Stay Informed
    Gain insight from a variety of resources.

    In the past, I would say call notified bodies and stay in communication with them—but not right now. The best thing to do is get on their blogs, track their website, follow their webinars. If they’re having courses, meetings, or learning sessions, go to those sources to get as much important information as possible until it’s appropriate to start conversing with your Notified Body.

    Notified Bodies are most likely all doing something different, setting different boundaries, and establishing different transition requirements. Regardless of what the regulations say, Notified Bodies are functioning based on their own processes, limitations, and resources.

    Other useful resources to follow include:
    • The Competent Authorities for Medical Devices (CAMD) Implementation Task Force: Review its timeline and see how the organization is progressing with the timeline. Also, determine where the organization is with implementing its rolling plan.
    • European Commission (EC): The organization frequently releases common specifications. For instance, last October, it released the common specification for infusion pumps.
    These steps will help you be more prepared for when you start working with your Notified Body. The more information you can gather from all these resources, the better off you will be in making the transition.

    Conclusion
    To get back up to speed with MDR/IVDR preparations, work through these four tasks multiple times. I don’t recommend you outsource these tasks, even if your team is overloaded. I think it’s important your team understands the processes and are trained and comfortable with them. Until your team is at that point, it doesn’t make sense to outsource these transition activities.

    Given the amount of work that needs to be done in a short amount of time, as well as the extent of changes with the new regulations, Notified Bodies will want your processes to be laid out in a way that is easy for them to follow. They need companies to fully understand their own products, processes, and transition situation and to be able to clearly communicate them. Most importantly, stay informed, revisit your plan frequently, continue to evolve your perception of the transition, and keep moving forward. 


    Nicolle Cannon is the founder and CEO of Cannon Quality Group LLC, a full-service, outsourced quality management organization, specializing in supporting startups and early-stage medical device companies. Cannon Quality Group has been serving clients for more than 10 years. Prior to starting a consulting business, Cannon worked in quality for various medical device companies, including FoxHollow Technologies, Advanced Stent Technologies, and AVE/Medtronic. She holds a bachelor of science degree in mechanical engineering from Cal Poly State University. 
      Loading, Please Wait..

      Trending
      • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
      • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
      • A New Approach To Post-Market Surveillance
      • Tessy Plastics Corp. Celebrates 50th Anniversary
      • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
      Breaking News
      • MPO's Most-Read Stories This Week—March 25
      • Getinge iCast Receives FDA Premarket Approval
      • Tessy Plastics Corp. Celebrates 50th Anniversary
      • Carium Expands Customization Options with Care Pathways
      • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
      View Breaking News >
      CURRENT ISSUE

      March 2023

      • Sensing Technology Drives the Future of Medical Care
      • New and Developing Diabetes Technologies Offer 'Sweet Relief'
      • Discussing Matters of Substance in Medtech Materials
      • Medical Device Testers Are Caught Up in a Whirlwind
      • 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

      NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
      GOOD Meat Receives FDA Go-Ahead for Cultured Meat
      IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
      Coatings World

      Latest Breaking News From Coatings World

      HOFFMANN MINERAL to Focus on Comprehensive Sustainability Strategy
      HMG and Prodrive Renew Technical Partnership
      Eastern Coatings Show Sets Schedule for Technical Papers
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—March 25
      Getinge iCast Receives FDA Premarket Approval
      Tessy Plastics Corp. Celebrates 50th Anniversary
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Willow, Suanfarma Complete Manufacturing Process for Cannabigerol
      Berkshire Sterile to Install nearly 1,500 solar panels at Massachusetts site
      Harm Reduction Therapeutics, Catalent Ink Naloxone Commercial Supply Pact
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Interpack 2023 Introduces New Special Areas and Activities
      eSalon Expands into Over 1,900 CVS Stores Nationwide
      The RealReal Discontinues Beauty Business
      Happi

      Latest Breaking News From Happi

      ‘Glossier You’ Returns to Glossier’s Fragrance Portfolio
      Mielle Expands Pomegranate & Honey Collection with Debut of Air Dry Stylers
      Metallic Pigments Market Forecasted to Reach $3.4 Billion by 2033
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Packaging Inks, Toyo Ink Top This Week’s Stories
      Eastern Coatings Show Announces Schedule for Technical Papers
      Pulse Roll Label Products Adds Sean Labas to Technical Sales Team
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Imageworx details new facility, Avery Dennison tackles recycling and more
      TLMI announces 2022 Eugene Singer Award winners
      Pulse Roll Label Products expands technical sales team
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Weekly Recap: Heartland Polymers Begins Production, Zeta Polimeri Becomes Radici EcoMaterials & More
      Heartland Polymers Begins Production in Alberta
      Zeta Polimeri Becomes Radici EcoMaterials
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most-Read Stories This Week—March 25
      AI is Effective at Documenting Orthopedic Encounters in Hand Surgery
      3D LifePrints Rebrands to Insight Surgery & Launches New Business in Houston
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Dave Rahami, Zebra, Dracula Technologies Top This Week’s Stories
      Midsummer, UCLA Collaborate on Perovskite-CIGS Tandem Solar Cells
      HID Reports on Reshaping the Security Industry

      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