• 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
    Researchers Develop New Global Estimate of Medicinal Plant Species and Conservation Status

    All Eyes on Vision Health

    Health Benefits of Vitamin K: A Contemporary Cornerstone of Heart and Bone Health

    Vitamin D: A Fixture of Supplementation and Fortification

    Magnesium: An Essential Mineral with Many Forms and Functions
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Nutrasource Rebrands Clinical Trial Site to Apex Trials

    Kerry Sponsors Upcycled Food Foundation Research Fellowship

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients

    Vitamin D Supplementation Reduces Risk of Dynapenia

    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    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

    Natural Products Association Blasts FDA for Punting CBD Issues to Congress

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients

    FDA Denies CBD Petitions, Cites Safety Concerns, Looks to Congress for New Regulatory Pathway

    Vitamin D Supplementation Reduces Risk of Dynapenia

    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    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

    Nutrasource Rebrands Clinical Trial Site to Apex Trials

    Natural Products Association Blasts FDA for Punting CBD Issues to Congress

    Kerry Sponsors Upcycled Food Foundation Research Fellowship

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients

    FDA Denies CBD Petitions, Cites Safety Concerns, Looks to Congress for New Regulatory Pathway
    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

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients

    Vitamin D Supplementation Reduces Risk of Dynapenia

    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits

    Multi-Strain Probiotic Improves Self-Reported Mood, Sleep, Serotonin Levels

    CRN Highlights 'Supplement to Savings' Report for National Heart Month
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Bioactive Services

    Botanic Healthcare LLC

    JRS Pharma

    Chenguang Biotech Group Co., Ltd.

    Xsto Solutions
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Bioactive Services

    Botanic Healthcare LLC

    JRS Pharma

    Chenguang Biotech Group Co., Ltd.

    Xsto Solutions
    • 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
    Related CONTENT
    • Vitamin D: A Fixture of Supplementation and Fortification
    • Everwell Health Appoints Two to Executive Leadership Positions
    • Sabinsa Founder Dr. Muhammed Majeed Publishes Book on Selenium Research
    • NOW Switches to Bottles Made from 100% Post-Consumer Recycled Resin
    • Vitamin D Use Linked to Lower Melanoma Incidence
    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
    • World Markets
    • Regulations
    • Healthcare Trends
    Suggested For You
    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
    Botanical Adulterants Prevention Program Publishes Bulletin on Arnica Flowers Botanical Adulterants Prevention Program Publishes Bulletin on Arnica Flowers
    Large-Scale Review Breaks Down Cardiovascular Effects of 27 Nutrients Large-Scale Review Breaks Down Cardiovascular Effects of 27 Nutrients
    Personalized Nutrition: A Steep Learning Curve for the Dietary Supplement Market Personalized Nutrition: A Steep Learning Curve for the Dietary Supplement Market
    NOW Receives Earth Flag Award and Recognition for Philanthropy NOW Receives Earth Flag Award and Recognition for Philanthropy
    Hyaluronic Acid Matrix: Reimagining HA for Mobility and Beauty Hyaluronic Acid Matrix: Reimagining HA for Mobility and Beauty
    NOW: Magnesium Supplements On Amazon Fail Tests NOW: Magnesium Supplements On Amazon Fail Tests

    Related Features

    • Bone & Joint Health | Delivery & Dosage Technologies | Dietary Supplements | Immune Function | Research | Vitamins
      Vitamin D: A Fixture of Supplementation and Fortification

      Vitamin D: A Fixture of Supplementation and Fortification

      The most widely-supplemented nutrient continues to prevail in large-scale studies on immunity, healthy aging, and more.
      By Mike Montemarano, Associate Editor 01.20.23

    • Breaking News | Dietary Supplements | People News
      Everwell Health Appoints Two to Executive Leadership Positions

      Everwell Health Appoints Two to Executive Leadership Positions

      The company appointed Volkan Eren as VP of sales and business development and Catherine Kwik-Uribe, PhD, as VP of scientific and regulatory affairs.
      01.18.23

    • Breaking News | Dietary Supplements | Immune Function | Research | Supplier News
      Sabinsa Founder Dr. Muhammed Majeed Publishes Book on Selenium Research

      Sabinsa Founder Dr. Muhammed Majeed Publishes Book on Selenium Research

      The publication discusses selenium’s involvement in immune, thyroid, GI, and reproductive functions, as well as cancer therapy and skin and hair health.
      01.13.23


    • Breaking News | Consumer Trends | Dietary Supplements | Packaging | Products
      NOW Switches to Bottles Made from 100% Post-Consumer Recycled Resin

      NOW Switches to Bottles Made from 100% Post-Consumer Recycled Resin

      The company estimates that over 3 million pounds of plastic will be diverted in the first year.
      01.13.23

    • Breaking News | Cancer Risk | Dietary Supplements | Medical Nutrition | Research | Research News | Vitamins
      Vitamin D Use Linked to Lower Melanoma Incidence

      Vitamin D Use Linked to Lower Melanoma Incidence

      The cross-sectional study included 500 adults at an increased risk of skin cancer.
      01.12.23

    Loading, Please Wait..
    Trending
    • NOW Switches To Bottles Made From 100% Post-Consumer Recycled Resin
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • The Functional Chocolate Company Launches Painfree Chocolate
    Breaking News
    • Nutrasource Rebrands Clinical Trial Site to Apex Trials
    • Kerry Sponsors Upcycled Food Foundation Research Fellowship
    • Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients
    • Vitamin D Supplementation Reduces Risk of Dynapenia
    • Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    View Breaking News >
    CURRENT ISSUE

    Jan/Feb 2023

    • Healthy, Clean Label Snacks and Nutrition Bars Help Fill Nutrient Gap Cleaved By Modern Lifestyles
    • Magnesium: An Essential Mineral with Many Forms and Functions
    • Vitamin D: A Fixture of Supplementation and Fortification
    • Health Benefits of Vitamin K: A Contemporary Cornerstone of Heart and Bone Health
    • All Eyes on Vision Health
    • Researchers Develop New Global Estimate of Medicinal Plant Species and Conservation Status
    • 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

    Nutrasource Rebrands Clinical Trial Site to Apex Trials
    Kerry Sponsors Upcycled Food Foundation Research Fellowship
    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant Medical Closes $75M Financing Round
    Know Labs Founder Ron Erickson Named CEO
    Getinge's Recall of Cardiosave Hybrid and Rescue IABPs is Class I
    Contract Pharma

    Latest Breaking News From Contract Pharma

    SK bioscience Introduces New Global Partnership Model for Vaccines
    Merck's KEYTRUDA Wins Expanded Approval in Non-Small Cell Lung Cancer
    Bone Biologics Engages Avania for NB1 Clinical Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    LVMH Reports Record 2022
    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Happi

    Latest Breaking News From Happi

    Net Sales for Colgate-Palmolive Increase 5%
    Uncle Funky’s Daughter Announces Retail Expansion
    Scott’s Liquid Gold Sells Wood and Floor Care Brands
    Ink World

    Latest Breaking News From Ink World

    Roland DGA Announces Major Expansion of TrueVIS Printer Family
    Neos Expands Production Capacity, European Market Presence
    Celanese Launches Nine New Conductive Inks for Consumer Applications
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Channeled Resources launches blank labels with PET liner
    Infigo partners with Four Pees in Benelux region
    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Roche, Sysnav Partner on Movement Tracking Tech for Neuromuscular Disorders
    Orthopedic Braces/Support, Casting/Splints Market to Top $12B by 2030
    Orthofix Launches the Mariner Deformity System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Celanese Launches Nine New Conductive Inks
    NREL Develops Thin, Lightweight Layer for Radiation Barrier for Perovskites in Space
    LG Display Reports Fourth Quarter 2022 Results

    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