medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Vigilance

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

New EU guidance on medical devices vigilance reporting – more than meets the eye

Update on Eudamed and its implications for vigilance in the EU

New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

EU court rules on no-fault liability for medical services with medical devices

Outlines of the medical devices Recast become more fixed with Council conclusions

Eudamed enters into full force

  • 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

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  • Medicaldeviceslegal tweets

    • EU #MDR and #IVDR transitioning - where are you in your process? #medicaldevices #IVDs medicaldeviceslegal.com/2017/08/03/mdr… 2 weeks ago
    • An unsurprising case of #software as #medicaldevice under EU #medicaldevices law medicaldeviceslegal.com/2017/07/31/an-… 2 weeks ago
    • Netherlands to adopt act on #medicaldevices hospitality and Sunshine reporting medicaldeviceslegal.com/2017/06/05/net… https://t.co/QwnWuqyJFf 2 months ago
    • #medicaldevices #IVDs #medtech twitter.com/meddevlegal/st… 3 months ago
    • RT @mstrubin: Glad to speak at #eHealthWeek on 10 May in the session "Nobody said it would be easy" on @EURO_CAS and #interoperability. @eH… 3 months ago
    • Final MDR and IVDR texts published medicaldeviceslegal.com/2017/05/05/fin… https://t.co/BV73UcRto5 3 months ago
    • Check out our session on #medicaldevices and #dataprotection compliance in global big data at 11:00 today at #GMTCC gmtcc.com/programme-2017 3 months ago
    • New EU #medicaldevices and #IVD regulations to be published this Friday medicaldeviceslegal.com/2017/05/03/mdr… https://t.co/y0jK0x4jqi 3 months ago
    • RT @EU_Growth: New rules for #MedicalDevices🌡️ adopted by @Europarl_EN for better patient protection and greater transparency: https://t.co… 4 months ago
    • EU SCHEER scientific advice on breast implants published, consultation until 7 May #medicaldevices #breastimplants ec.europa.eu/newsroom/sante… 4 months ago

  • Most used tags on this blog

    3D printing advertising apps authorised representative borderline business compliance CE mark 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 promotion 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

    醫療軟體公司應盡快實施MDR… on An unsurprising case of softwa…
    Julie O. on MDR and IVDR transitioning…
    Erik Vollebregt on MDR and IVDR transitioning…

  • Most used categories on this blog

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

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