All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Biosimilars
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Radiopharmaceuticals
    • Science '22 in Review
    • Top Biopharma Trends of 2022
    • Top Med-tech Trends of 2022
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • sign in
  • Sign Out
  • My Account
Subscribe
BioWorld - Tuesday, May 30, 2023
See today's BioWorld MedTech
Home » MDR brings clarity to EU software product classification
X
/images/Cortellis_Flagship_Logo_TM_RGB_Color.png

Upgrade your daily dose of biopharma and medtech news

Subscribe to BioWorld™ news services

See subscription options
To read the full story, subscribe or sign in.
Moving on up

MDR brings clarity to EU software product classification

Nov. 18, 2019
By Nuala Moran
No Comments
LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
BioWorld MedTech Software Digital health Europe

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 30, 2023.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for May 30, 2023.
  • FDA approved icons and medical professional

    Genmab, Abbvie to join Roche with FDA nod for CD20 bispecific in lymphoma

    BioWorld
    Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for...
  • Illustration of pancreas

    Gene therapy to reverse T2D shows proof of concept at ASGCT

    BioWorld
    The most ambitious objective of any treatment is to eradicate the disease, acting on its origin to cure it instead of treating its symptoms. This is the purpose...
  • Clinical data illustration

    Medtronic, Philips, Edwards late-breaking study data spotlighted at EuroPCR

    BioWorld MedTech
    Among the many companies presenting data at the EuroPCR conference in Paris, several late breaking trials from heavy hitters Medtronic plc, Royal Phillips NV and...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing