• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

EU MDR

EU allows remote audits for medical devices during pandemic

January 12, 2021 By Nancy Crotti Leave a Comment

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic […]

Filed Under: Business/Financial News, Diagnostics, Featured, Regulatory/Compliance Tagged With: bsi, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech Europe gives proposed European Health Union a partial nod

November 20, 2020 By Nancy Crotti

MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from […]

Filed Under: Business/Financial News, Clinical Trials, Diagnostics, Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech 100 roundup: Stocks remain high after record-setting week

November 16, 2020 By Sean Whooley

Medtech stocks have been on the rise since positive news regarding COVID-19 vaccines broke last week, breaking a record in the process. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.99 (Nov. 13), marking a 1.4% uptick from the 97.62 points registered at the […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, Funding Roundup, Initial Public Offering (IPO), MassDevice Earnings Roundup, Mergers & Acquisitions, Pharmaceutical, Research & Development, Wall Street Beat Tagged With: 3m, Baxter, coronavirus, COVID-19, EU MDR, Joe Biden, MedTech 100 Index, Sotera Health, Stryker, Wright Medical

How major medtech companies are responding to the looming EU MDR

November 10, 2020 By Nancy Crotti

Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once. The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: AdvaMed, becton dickinson, bsi, EU MDR, Johnson & Johnson, Medline Industries Inc., MedTech Europe, Smith+Nephew

BREAKING: EU-MDR is postponed by 1 year due to coronavirus pandemic

April 17, 2020 By Nancy Crotti

The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU MDR, European Commission, European Parliament, MedTech Europe

DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news

March 27, 2020 By Tom Salemi

In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]

Filed Under: Business/Financial News, Contract Manufacturing, Device Talks Podcasts, Featured, Legal News, Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, DeviceTalks Weekly, EU MDR, Fang Consulting, FDA, Hogan Lovells

European Commission to ask for EU MDR enforcement delay

March 25, 2020 By Sean Whooley

The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic. Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in […]

Filed Under: Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU MDR, European Commission

MedTech Europe wants halt of EU MDR implementation amid coronavirus crisis

March 23, 2020 By Sean Whooley

Trade association MedTech Europe announced today that it is calling on EU institutions to postpone the implementation of the new Medical Devices Regulation and In Vitro Diagnostics Regulation (IVDR) amid the outbreak of COVID-19. Medical device companies have been scrambling to meet the implementation of the new MDR and IVDR. May 26 has been a […]

Filed Under: Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU IVDR, EU MDR, MedTech Europe

10 medical device industry stories you need to know

December 27, 2019 By Chris Newmarker

From leadership changes to tax repeal to robots — lots of robots — this was a busy year for the medical device industry. Here are 10 stories in the medtech space that especially caught the eye of MassDevice and Medical Design & Outsourcing editors and readers in 2019. Next>>

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Orthopedics, Regulatory/Compliance, Robotics, Surgical Tagged With: Abbott, ethylene oxide, EU MDR, FDA, Intuitive Surgical, Johnson & Johnson, Medtronic, robot-assisted, Stryker, tariffs, Theranos, Women in Medtech

MedTech Europe slams EU over lack of preparation for MDR/IVDR

November 26, 2019 By Nancy Crotti

With six months to go before the EU’s new Medical Device Regulation takes effect, Europe’s medtech trade association is accusing government authorities of dragging their feet on the process. MedTech Europe said that the industry is trying to prepare but that it remains “seriously held back by the slow and piecemeal implementation” of the new […]

Filed Under: Diagnostics, Featured, Regulatory/Compliance Tagged With: EU IVDR, EU MDR, MedTech Europe, Oriel Stat A Matrix

Report: Most medical device makers not ready to meet E.U. MDR deadline

September 24, 2019 By Chris Newmarker

Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG. The survey — which closed in late June and was released […]

Filed Under: Featured, News Well, Regulatory/Compliance Tagged With: EU MDR, European Union, KPMG, RAPS

  • Go to page 1
  • Go to page 2
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS

  1. themes/genesis/config/layouts.php
  2. themes/genesis/config/requirements.php
  3. themes/genesis/footer.php
  4. themes/genesis/functions.php
  5. themes/genesis/header.php
  6. themes/genesis/lib/admin/term-meta.php
  7. themes/genesis/lib/admin/user-meta.php
  8. themes/genesis/lib/classes/class-genesis-requirements-views.php
  9. themes/genesis/lib/classes/class-genesis-script-loader.php
  10. themes/genesis/lib/classes/class-genesis-search-form.php
  11. themes/genesis/lib/css/load-styles.php
  12. themes/genesis/lib/framework.php
  13. themes/genesis/lib/functions/breadcrumb.php
  14. themes/genesis/lib/functions/compat.php
  15. themes/genesis/lib/functions/deprecated.php
  16. themes/genesis/lib/functions/feed.php
  17. themes/genesis/lib/functions/formatting.php
  18. themes/genesis/lib/functions/general.php
  19. themes/genesis/lib/functions/head.php
  20. themes/genesis/lib/functions/image.php
  21. themes/genesis/lib/functions/layout.php
  22. themes/genesis/lib/functions/markup.php
  23. themes/genesis/lib/functions/menu.php
  24. themes/genesis/lib/functions/open-graph.php
  25. themes/genesis/lib/functions/options.php
  26. themes/genesis/lib/functions/post-meta.php
  27. themes/genesis/lib/functions/requirements.php
  28. themes/genesis/lib/functions/rest.php
  29. themes/genesis/lib/functions/seo.php
  30. themes/genesis/lib/functions/toolbar.php
  31. themes/genesis/lib/functions/upgrade.php
  32. themes/genesis/lib/functions/version.php
  33. themes/genesis/lib/functions/widgetize.php
  34. themes/genesis/lib/init.php
  35. themes/genesis/lib/js/load-scripts.php
  36. themes/genesis/lib/shortcodes/footer.php
  37. themes/genesis/lib/shortcodes/post.php
  38. themes/genesis/lib/structure/archive.php
  39. themes/genesis/lib/structure/comments.php
  40. themes/genesis/lib/structure/footer.php
  41. themes/genesis/lib/structure/header.php
  42. themes/genesis/lib/structure/layout.php
  43. themes/genesis/lib/structure/loops.php
  44. themes/genesis/lib/structure/menu.php
  45. themes/genesis/lib/structure/post.php
  46. themes/genesis/lib/structure/sidebar.php
  47. themes/genesis/lib/widgets/featured-page-widget.php
  48. themes/genesis/lib/widgets/featured-post-widget.php
  49. themes/genesis/lib/widgets/user-profile-widget.php
  50. themes/genesis/lib/widgets/widgets.php
  51. themes/genesis/searchform.php
  52. themes/genesis/sidebar.php
  53. themes/news-pro/functions.php
  54. themes/news-pro/lib/customize.php
  55. themes/news-pro/lib/helper-functions.php
  56. themes/news-pro/lib/output.php
  57. themes/news-pro/lib/theme-defaults.php
  58. themes/news-pro/lib/woocommerce/woocommerce-notice.php
  59. themes/news-pro/lib/woocommerce/woocommerce-output.php
  60. themes/news-pro/lib/woocommerce/woocommerce-setup.php