medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Tag browsing: guidance

A wave of MDR and IVDR rollout coming our way

Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

New EU Commission guidance on medical devices borderline products and classification

  • Erik Vollebregt

    Erik is a founding partner of the boutique life sciences law firm Axon Lawyers and specialised in EU legal and regulatory issues relating to medical technology

  • Enter your email address to subscribe to this blog and receive notifications of new posts by email.

    Join 5,756 other followers

  • Subscribe via RSS

    RSS Feed RSS - Posts

    RSS Feed RSS - Comments

  • All content on this blog is subject to a Creative Commons Licence

  • Medicaldeviceslegal tweets

    • The Commission and the Council on the #MDR state of affairs #medicaldevices #medtech #eumdr medicaldeviceslegal.com/2019/12/10/the… https://t.co/coF7fV5s3Y 16 hours ago
    • #Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices #medtech… twitter.com/i/web/status/1… 2 days ago
    • #Eudamed delayed, but #MDR not delayed - now what? #medicaldevices #medtech #IVDR medicaldeviceslegal.com/2019/11/19/eud… https://t.co/kZQblUstOU 6 days ago
    • Counting down to the #MDR date of application, and the legal stuff to get right before end May 2020 #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 3 months ago
    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 4 months ago
    • Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 5 months ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 6 months ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 7 months ago

  • Most used tags on this blog

    3D printing advertising apps authorised representative borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR competition law conferences Council Cybersecurity Dalli data protection DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR genetic testing GHTF HCP hospitals in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny Security seminar software standalone software standards subcontractors telemedicine transition plan transparency trilogue UDI Unannounced audits vigilance

  • Recent comments

    Michael Wienholt on The Commission and the Council…
    Axon Lawyers –… on Eudamed delayed, but MDR not d…
    Erik Vollebregt on Eudamed delayed, but MDR not d…

  • Most used categories on this blog

    Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA Intellectual property In Vitro Diagnostics Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance

  • Archives

Blog at WordPress.com.