medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Standards

Standardisation request for MDR and IVDR refused; now what?

Team NB FAQ on EN62304 standard for software lifecycle processes

CE marking of apps: It Can Be Done and Here Is How

Regulating Medical Software and nothing new on the Recast

Standardisation, anyone?

ISO 14155:2011 is here: revised standards for medical devices clinical trials

New standard for medical technology used at home

Software design for medical devices

New EU competition rules on R&D, information exchange and standards

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap… 2 months ago
    • The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.… twitter.com/i/web/status/1… 2 months ago
    • The new EU AI regulation proposal and its impact for EU medical devices and IVDs regulation #MDR #IVDR… twitter.com/i/web/status/1… 2 months ago
    • #MDR date of application next month - and the Enriched MDR and IVDR book #IVDR #economicoperators #swixit #turkxit… twitter.com/i/web/status/1… 3 months ago
    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 6 months ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 7 months ago
    • The #Brexit ‘deal’ has finally dropped - what’s in it for the #medicaldevices industry? #MDR #IVDR #medtech #eudmr… twitter.com/i/web/status/1… 7 months ago
    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 1 year ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 1 year ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 1 year ago

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  • Recent comments

    Health Care Faciliti… on IVDR, in-house developed tests…
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    Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA In Vitro Diagnostics IVDR Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance

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