• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

    (Re)Open for Business: China’s Strong Demand for Natural Products Spells Opportunity for U.S. Brands

    Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders

    KA! Empathogenics: Creating Calm and Connectedness with Inspiration from Nature

    Moms Raise the Bar for Kids Supplements
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Gaming and Esports Health Concerns

    Bioiberica’s DAOgest Authorized as Novel Food ingredient in EU

    Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Verdure Sciences

    Nutrition21, LLC

    Aiya America, Inc. (Aiya Matcha)

    KLK OLEO
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    JRS Pharma

    Verdure Sciences

    Nutrition21, LLC

    Aiya America, Inc. (Aiya Matcha)

    KLK OLEO
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    A Bottleneck in Certification of Medical Devices Could Impact Patient Care in the EU

    A proposed extension for the implementation period of new regulation might help, but companies need to be diligent.

    A Bottleneck in Certification of Medical Devices Could Impact Patient Care in the EU
    By Joerg Gruenwald, analyze & realize GmbH01.20.23
    In the EU, the new Medical Devices Regulation (EU) 2017/745 (MDR) entered into force in May 2017, replacing the old Medical Device Directive (MDD; 93/42/EEC medical devices).

    This action entailed major changes for the majority of the self-certified former CE class I medical devices, which are now assigned higher risk classes. It applies also for substance-based devices such as nasal sprays, throat lozenges, topical products, and many others. The European Parliament approved an extension of the re-certification period until May 26, 2024.

    A similar situation exists for in vitro diagnostic medical devices (IVD). These products are designed for testing of human samples (such as salvia, blood, urine, feces, or tissues) outside the body to provide information on a person’s health or physiological state. Until 2017, IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force.

    The IVDD-to-IVDR transition period ended in May 2022, and like for medical devices, there will be a further grace period for certain devices until May 2024.

    For a period of 3 years following the entry into force of the MDR, manufacturers could decide to certify their products either under the new MDR or under the old MDD. However, since May 2020, this is no longer possible. All medical devices now require new certification by a Notified Body (NB). Nonetheless, NBs can only certify for the MDR after they have been designated for it.

    Shortage of Notified Bodies Leads to Bottlenecks

    However, it has been obvious since 2019 that there are not enough Notified Bodies to carry out the certification, considering the number of existing medical devices in relation to the number of Notified Bodies. In the EU, there are 33 Notified Bodies designated for the MDR and only seven Notified Bodies designated for the IVDR. This illustrates the need for Notified Bodies.

    The lack of certified NBs is a bottleneck for the certification of new medical devices (and re-certification of existing devices that were originally certified under the old legislation), which means that those medical devices whose manufacturers are unable to find a Notified Body will have to be withdrawn from the market at the end of the transitional period.

    The same is true for devices certified under implementation of the IVDR, where there are even fewer Notified Bodies available than for the MDR.

    Real Implications for Patient Care

    This is not a trivial problem; many medical devices are vital parts of patient care, and a lack of them would endanger successful treatments and even lives.

    In order to prevent this, several industry associations called for an extension of the transitional period. In October 2022, the German Bundesrat urgently appealed to the German Federal Government to clearly and vehemently advocate at the EU level for improvements in the implementation of the EU MDR and the IVDR.

    The resolution proposes reasonable measures to ensure adequate patient care after May 2024. Measures include immediate solutions for orphan products, simplified implementation for legacy devices, more capacity for as well as more Notified Bodies, and a call on the EU Commission to consider extending the implementation period in order to lessen the certification bottleneck.

    Proposed Action

    On Dec. 9, 2022 the European Commission finally proposed a further extension of the MDR transition period during the EPSCO meeting in Brussels.

    For devices with a higher risk class (class III and Class IIb), the proposed extension is until 2027, while lower risk class devices—of which there are many more on the market—may expect an extension until 2028.

    MDD device certificates of legacy devices are planned to be valid at least until the respective certificate’s expiration date. Under certain conditions, the validity can be extended. These conditions include no unacceptable risk to health and safety posed by the device, and no significant changes in its design or intended purpose. Also, manufacturers must have adapted their quality management system to MDR, and their application for conformity assessment must have been accepted by a Notified Body.

    MD manufacturers are now awaiting the outcome of the legislative proposal to the European Parliament, which is expected to be provided by the European Commission in early 2023.

    In any case, food and business operators that still have legacy devices registered under the old MDD on the market should speedily upgrade their documentation to MDR.

    This requires the realization of selected legal requirements which are new and most challenging for manufacturers of MDD class I devices. It entails acquiring relevant clinical data to prove the performance and safety of the device. Also, there are new fundamental requirements regarding implementation and running of the Post-Market Surveillance and vigilance system. Experienced consultancies such as analyze & realize GmbH stand ready to assist.


    About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; jgruenwald@a-r.com.
    Related Searches
    • Healthcare Trends
    • Regulations
    • World Markets
    Related Knowledge Center
    • Regulations
    • Healthcare Trends
    • World Markets
    Suggested For You
    Nature’s Bounty Reveals Women’s Health Supplements for Hair Growth and Weight Management Nature’s Bounty Reveals Women’s Health Supplements for Hair Growth and Weight Management
    NIH Study Estimates Economic Burden of Health Disparities By Race, Ethnicity, Education NIH Study Estimates Economic Burden of Health Disparities By Race, Ethnicity, Education
    Hydrolyzed Cartilage Matrix Linked to Self-Reported Joint Improvements Hydrolyzed Cartilage Matrix Linked to Self-Reported Joint Improvements
    Kaneka Nutrients to Spotlight Ubiquinol at Vitafoods Europe Kaneka Nutrients to Spotlight Ubiquinol at Vitafoods Europe
    AHPA Requests FTC to Expand Scope of Green Guides AHPA Requests FTC to Expand Scope of Green Guides
    Boosting Immune Health by Protecting Against Toxins with Glucarate Boosting Immune Health by Protecting Against Toxins with Glucarate
    Vitamin D: A Fixture of Supplementation and Fortification Vitamin D: A Fixture of Supplementation and Fortification
    Everwell Health Appoints Two to Executive Leadership Positions Everwell Health Appoints Two to Executive Leadership Positions
    Sabinsa Founder Dr. Muhammed Majeed Publishes Book on Selenium Research Sabinsa Founder Dr. Muhammed Majeed Publishes Book on Selenium Research
    NOW Switches to Bottles Made from 100% Post-Consumer Recycled Resin NOW Switches to Bottles Made from 100% Post-Consumer Recycled Resin
    Vitamin D Use Linked to Lower Melanoma Incidence Vitamin D Use Linked to Lower Melanoma Incidence
    Artemis International Appoints Randy Kreienbrink as VP of Sales Artemis International Appoints Randy Kreienbrink as VP of Sales
    BGG Receives USP Award for Work on Elderberry Extract BGG Receives USP Award for Work on Elderberry Extract
    Kerry Appoints Bruce Brown as VP of Supplements in North America Kerry Appoints Bruce Brown as VP of Supplements in North America
    MycoTechnology’s FermentIQ Ingredients Receive EU Approval MycoTechnology’s FermentIQ Ingredients Receive EU Approval

    Related Breaking News

    • Dietary Supplements | Minerals | Research | Vitamins | Weight Management/Weight Loss | Women's Health
      Nature’s Bounty Reveals Women’s Health Supplements for Hair Growth and Weight Management

      Nature’s Bounty Reveals Women’s Health Supplements for Hair Growth and Weight Management

      The clinically studied formulas address common women’s health concerns.
      05.17.23

    • Breaking News | Healthcare Trends | Research News
      NIH Study Estimates Economic Burden of Health Disparities By Race, Ethnicity, Education

      NIH Study Estimates Economic Burden of Health Disparities By Race, Ethnicity, Education

      The total burden for race/ethnic health disparities cost the U.S. economy $451 billion, and the education disparity burden amounted to $978 billion.
      05.17.23

    • Bone & Joint Health | Dietary Supplements | Proteins, Peptides, Amino Acids
      Hydrolyzed Cartilage Matrix Linked to Self-Reported Joint Improvements

      Hydrolyzed Cartilage Matrix Linked to Self-Reported Joint Improvements

      A study digitally-enabled study showed significant improvements compared to placebo in real-world conditions, thanks to self-reporting on smartphones.
      05.08.23


    • Antioxidants
      Kaneka Nutrients to Spotlight Ubiquinol at Vitafoods Europe

      Kaneka Nutrients to Spotlight Ubiquinol at Vitafoods Europe

      The company will focus on the CoQ10 ingredient’s new positioning for healthy aging, beauty from within, and sports recovery.
      04.28.23

    • Breaking News | Industry & Market News | Packaging | Regulations
      AHPA Requests FTC to Expand Scope of Green Guides

      AHPA Requests FTC to Expand Scope of Green Guides

      The trade association believes the agency should exert more authority on the standards for several kinds of environmental claims.
      04.26.23

    Loading, Please Wait..
    Trending
    • Soviets Took Probiotics To The Next Level
    Breaking News
    • Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    • BGG Receives Patent for Saw Palmetto ID Method
    • Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    • Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    • Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Cellular Aging and Longevity: Ingredients for a New Age of Health
    • Addressing the Plastic-Packaging Problem: Getting to Zero-Waste with Zero Compromise
    • Moms Raise the Bar for Kids Supplements
    • Building on Steps to Improve Children’s Health Around the World
    • FDA Remains Focused on Modernizing DSHEA
    • 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

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Coatings World

    Latest Breaking News From Coatings World

    Boeing Starts Construction on New St. Louis Facility
    Brand Finance: Post-COVID Recovery Slows for Chemicals Industry Battling Energy Crisis
    BCF Calls for Greater Urgency on REACH Impasse
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CareDx, Miromatrix Collaborate on Bioengineered Organs Research
    Capitainer Releases to Market its Fully Automated Sample Handler
    Titan Medical Licenses Most IP to Intuitive; CEO Steps Down
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AVROBIO Sells Cystinosis Gene Therapy for $87.5 Million
    Meiji Seika Pharma, Adcock Ingram Pharma Complete Construction of New Manufacturing Facility
    JSR Life Sciences Consolidates KBI Biopharma and Selexis SA
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Unilever Uses AI for Product Development
    Beautycounter Names New Interim CEO
    Shaz & Kiks Available at Sephora
    Happi

    Latest Breaking News From Happi

    Covergirl Introduces Clean Fresh Yummy Gloss Collection
    Shaz and Kiks Launches at Sephora
    Beautycounter Appoints Board Director Mindy Mackenzie Interim CEO
    Ink World

    Latest Breaking News From Ink World

    ACTEGA, Makro Labelling to Advance Signite Technology
    BCF Requests Greater Urgency on REACH Impasse
    Updated Method Published for Entire BASF Product Portfolio
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ACTEGA teams with Makro Labelling to advance Signite technology
    Constantia Flexibles and SB Packagings commence joint venture
    Inland donates new VersaStudio printer to local high school
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Mann+Hummel Names President Air Filtration Americas
    KNH Launches Eco-Friendly Menstrual Pads
    Niine Introduces India's First PLA-Based Sanitary Pads
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Enrollment Completed in Anika Therapeutics' Hyalofast Study
    Exactech Releases Next-Gen GPS Shoulder
    Data Shows Favorable Survivorship of MISHA Knee System & Reduction of Arthroplasty Risk in Patients
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Presents Path to Accelerate Revenue Growth
    STMicroelectronics Introduces Waterproof MEMS Pressure Sensor
    Graphene Flagship to Join Euro Nano Forum 2023

    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