• 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
    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor

    Norman Noble Achieves ISO 13485:2016 Certification

    Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict

    Quell Wearable Neuromodulation Device Wins De Novo Authorization

    JenaValve Releases First Commercial Trilogy Heart Valve Implant Results in Europe
    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
    Cirtec Medical

    Fusion Biotec Inc.

    Concise Engineering

    Arthur G. Russell Co. Inc., The

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Fusion Biotec Inc.

    Concise Engineering

    Arthur G. Russell Co. Inc., The

    Trademark Plastics Inc.
    • 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

    TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation

    New regulation came into effect May 2017.

    TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation
    The European Medical Device Regulation 2017/745 (MDR) came into effect on May 25, 2017, and will replace Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD) on May 26 2020. Image courtesy of TÜV Rheinland.
    TÜV Rheinland10.01.19
    TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745. The European Medical Device Regulation 2017/745 (MDR) came into effect on May 25, 2017, and will replace Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD) on May 26 2020. “The EU Medical Device Regulation is much more comprehensive and detailed than the previous directives,” explained Zina Apostolou-Keiper, head of the Medical Business Field at TÜV Rheinland. “Due to the complexity of the newly created legal framework for medical devices, all market participants will in the future be subject to more stringent requirements.”
     
    New Eudamed Central Database
    A key element of the new MDR is the introduction of a central European database for medical devices (Eudamed). “The Eudamed database aims to improve market surveillance and transparency, ensure the traceability of medical devices and facilitate the flow of information among manufacturers and operators of medical devices, notified bodies, Member States and the EU Commission,” explained Apostolou-Keiper. Various databases are to be integrated in Eudamed, including the database for the registration of devices with a unique device identification (UDI) number as well as databases for economic operators, conformity assessment procedures, certificates, notified bodies, incidents and clinical studies.
     
    Increased Requirements for Notified Bodies
    In the opinion of the European Union institutions, the proper functioning of notified bodies is crucial for ensuring an even higher level of quality and safety of medical devices. The designation processes and procedures for monitoring notified bodies are now governed more comprehensively and defined in greater detail, with the aim of further harmonizing requirements. “For example, notified bodies are obligated to employ doctors and/or clinical experts to a greater extent and to ensure the rotation of lead auditors during monitoring audits,” said Apostolou-Keiper. Furthermore, it is now anchored in the legal text that notified bodies shall conduct an unannounced audit of the certificate holder at least once every five years. Dr. Hartung added “This is intended to provide greater certainty that manufacturers always produce their devices in full compliance with the applicable regulations. Product testing is also a key element of these audits.”
    Related Searches
    • unique device identification
    • it
    • dr
    • safety
    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA OKs J&J Vision's AcuVue Oasys Max 1-Day Contact Lenses
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Cepheid, BioGX Partner To Create GeneXpert Monkeypox Test
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    Breaking News
    • Enhatch Partners with Holo-Light to Deliver New Extended Reality Streaming Platform
    • Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    • Norman Noble Achieves ISO 13485:2016 Certification
    • Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    • Quell Wearable Neuromodulation Device Wins De Novo Authorization
    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

    Kensing Acquires Vitae Naturals
    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Coatings World

    Latest Breaking News From Coatings World

    PPG to Increase U.S. Aerospace Products Manufacturing Output to Meet Rising Demand
    Solvay to Discontinue Use of Fluorosurfactants for Production of Fluoropolymers
    AkzoNobel Names New CEO
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    Norman Noble Achieves ISO 13485:2016 Certification
    Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Shimadzu Scientific Instruments Extends HQ Campus
    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
    Batavia Enters Commercial Manufacturing Business
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Naples Soap Company to Open New Store in Venice, Florida
    Nectar Recruits 8-Year-Old YouTube Star to Launch Her Own Bath & Body Line
    L'Oreal Exec Joins Function of Beauty
    Happi

    Latest Breaking News From Happi

    Rhode Island’s Department of Health, Raw Elements and Partners Expand Touch-Free Mineral Sunscreen
    Julee Wilson Named Executive Director of BeautyUnited
    Arey Launches Unisex Leave-In Conditioner
    Ink World

    Latest Breaking News From Ink World

    Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
    Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
    Ingevity Appoints Christine Stunyo as Chief Human Resources Officer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood introduces Sitexco Label L10 anilox cleaning system
    Germark makes double press investment in Bobst
    UPM Raflatac to enhance service capabilities at Mills River factory
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Rockline's Springdale Campus Achieves 15 Million Safe Work Hours
    Emmanuelle Picard to Join Ahlstrom-Munksjö's Executive Management Team
    Alkegen Completes Luyang Acquisition
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
    Lawrence Yellin Appointed as Fuse Medical CFO
    Researchers Discover Novel Patching Material for Bone Defects
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Avery Dennison Highlights New Approach to Apparel with ADX Lab
    trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments
    Hugo Boss Partners with Nedap for Global RFID Roll-out

    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