• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test

    Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial

    Acutus Medical Launches AcQCross Line Extension

    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex

    Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Trademark Plastics Inc.

    JBC Technologies

    Xact Wire EDM Corp.

    Concise Engineering

    BMP Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Trademark Plastics Inc.

    JBC Technologies

    Xact Wire EDM Corp.

    Concise Engineering

    BMP Medical
    • 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
    Breaking News

    MED-EL is First Hearing Implant Producer to Earn MDR Certification

    Delayed by one year, the MDR will apply to all manufacturers selling medical devices within Europe.

    Related CONTENT
    • iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System
    • Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor
    • FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant
    • Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers
    • FDA OKs Neocis' Yomi Dental Robot for Full Arch Implant Treatment
    MED-EL08.03.20
    MED-EL, an Austria-based global leader in cochlear and hearing implants technology, has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification.  
     
    On March 25, the company made an initial announcement on the newly earned certification after making an early commitment to adopt the MDR in 2016. For the last three years, it has worked to transition its devices and quality management system to meet the MDR’s new quality requirements.  
     
    Following a lengthy process to earn the new MDR certification, an internal cross-functional MDR team was established. Guided by senior management and led by Regulatory Affairs, the project team was divided into key topics, allowing groups of specialist subject matter experts to zero in on details over many months, tasked with performing an analysis of the implications that MDR compliance would have on MED-EL’s products and processes. All of these efforts results in the successful completion of the MDR audit last year. 
     
    Following successful conformity assessment to the new MDR, including an audit of the Quality Management System, MED-EL is also one of the world’s first manufacturers to receive certification for a number of product categories, including medical devices of the highest risk class (Class III), Class III Implantable Custom-Made Devices, and Class I reusable surgical instruments.   
     
    Under the MDR all devices fall into four basic categories (invasive, non-invasive, active and special rules) and are then further segmented into classes. Class III devices (the MDR includes active implantable medical devices) are the highest risk category. 
     
    Though the EU MDR was delayed by one year until next May (2021), it will apply to all manufacturers selling medical devices within Europe. The MDR aims to provide greater protection of public health and safety by setting out far more stringent requirements and obligations. Although there are widespread concerns that failure to meet the deadline for compliance might impact the availability and safety of medical devices in the European Union, MED-EL’s certification is positive news for ENT professionals and patients.   
     
    Amid widespread concerns that failure to meet the compliance deadline might impact the availability and safety of medical devices in the EU, MED-EL’s certification comes as a relief to many ENT professionals and patients. MED-EL has always been committed to providing safe and effective devices to the highest standards. With the MDR certification now in place, MED-EL is best placed to make effective use of the so-called MDR “grace period” to transition all its current devices to MDR before 2024, and to ensure continued uninterrupted access to its life-changing technologies.  
     
    MED-EL’s corporate director for Regulatory Affairs, Elizabeth Gfoeller, commented; “MDR certification is essential to our business and it took an incredible collective effort to ensure that we are compliant so far in advance of the 26th May deadline.  We committed to becoming an early MDR adopter back in 2016, in order to maintain our leadership in Europe. With MDR certification in place, we can now continue our mission to put an end to hearing loss and provide patients and practitioners with solutions that meet these new stringent standards.”  
     
    Suggested For You
    iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System
    Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor
    FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant
    Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers
    FDA OKs Neocis FDA OKs Neocis' Yomi Dental Robot for Full Arch Implant Treatment
    UArizona Scientist Develops New Cataract Replacement Lenses UArizona Scientist Develops New Cataract Replacement Lenses
    Boston Scientific Boston Scientific's Insertable Cardiac Monitor System Cleared by FDA
    Sinuva Approved by CMS for Reimbursement Sinuva Approved by CMS for Reimbursement
    Rice Team Makes Tiny, Magnetically Powered Neural Stimulator Rice Team Makes Tiny, Magnetically Powered Neural Stimulator
    FDA Issues Warning Letters to Two Breast Implant Makers FDA Issues Warning Letters to Two Breast Implant Makers
    HRS 2020 Science: Trial Data Compares Subcutaneous ICD Therapy to TV-ICDs HRS 2020 Science: Trial Data Compares Subcutaneous ICD Therapy to TV-ICDs
    MDR Delay Official; Industry Urges Push Back of IVDR MDR Delay Official; Industry Urges Push Back of IVDR
    Rice Joins U of U-Led Human Factors Consortium Rice Joins U of U-Led Human Factors Consortium
    Prent Supports the Fight Against COVID-19 Prent Supports the Fight Against COVID-19
    Brexit Deal Will Impact Medical Device Development in U.K. Brexit Deal Will Impact Medical Device Development in U.K.

    Related Breaking News

    • Software & IT | Surgical
      iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System

      iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System

      Gathers clinical evidence in support of the safety & performance of its investigational surgical tool.
      PRNewswire 09.29.20

    • Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor

      Exero Medical Completes First In-Human Implant of Wireless Anastomotic Leak Sensor

      Trial serves as proof of concept for the company’s early anastomotic leak detection system.
      Exero Medical 09.16.20

    • FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant

      FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant

      The Acclaim device offers the benefits of traditional partially implanted cochlear implants without the external components and associated disadvantages.
      Business Wire 08.28.20


    • Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers

      Study: PROPEL Sinus Implant is More Effective Treatment Than Non Drug-Eluting Spacers

      The device also saves money, as it helps reduce post-operative complications.
      Business Wire 08.14.20

    • Surgical
      FDA OKs Neocis

      FDA OKs Neocis' Yomi Dental Robot for Full Arch Implant Treatment

      Broadens Yomi’s application to include full arch implant and partially edentulous cases.
      GlobeNewswire 07.29.20

    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 7 Steps To Create Your Own Medical Device Marketing Plan
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • World’s First Non-Invasive, Saliva Glucose Biosensor
    Breaking News
    • Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test
    • Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    • Acutus Medical Launches AcQCross Line Extension
    • Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    • Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Japanese Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    United Plant Savers Launches First Film Festival
    Coatings World

    Latest Breaking News From Coatings World

    H.M. Royal Becomes Exclusive OCSiAl Distributor
    American Colors to Expand Sandusky, Ohio Facility
    Vaughn O’Dea Named Director of Epoxytec
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test
    Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    Acutus Medical Launches AcQCross Line Extension
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
    Pfizer, BioNTech Adapt COVID Vax Against Omicron
    CoreRx Expands Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
    John Frieda Supports the LGBTQIA+ Community
    Athena Club Launches in Canada
    Happi

    Latest Breaking News From Happi

    Past Henkel Exec Christian Chopra Named President of Scotch Porter
    Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
    CIR Panel Conducts 161st Meeting Regarding Safety Assessments for Cosmetic Ingredients
    Ink World

    Latest Breaking News From Ink World

    Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
    Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Harveer Sahni recognized with Global Achievement Award
    Color-Logic partners with Taktiful 
    ALTANA announces Management Board change
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
    Yanpai Orders Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Discover Novel Patching Material for Bone Defects
    Boston Centerless Opens Second Manufacturing Plant in Indiana
    Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
    LG Display Announces Winners of This Year’s OLEDs GO! Competition
    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

    Copyright © 2022 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