medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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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

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  • Medicaldeviceslegal tweets

    • Bottlenecks, #Brexit and stalling CAMD roll-out - a new post on #MDR and #IVDR implementation #medicaldevices… twitter.com/i/web/status/1… 1 week ago
    • #IVDR and #MDR implementation seminar on 18 May at @axonlawyers #medicaldevices #ivds medicaldeviceslegal.com/2018/04/12/ivd… https://t.co/3q4PQNRr2d 4 months ago
    • #MDR & #IVDR update after the first MDCG/stakeholders meeting and an IVD seminar at Axon Lawyers #medicaldevices… twitter.com/i/web/status/9… 4 months ago
    • An EU Court #medicaldevices #software qualification case with a twist #samd #mdr #MEDDEV medicaldeviceslegal.com/2018/01/12/an-… 7 months ago
    • Happy New Year - with the EU #MDR transition period going past halfway point #medicaldevices medicaldeviceslegal.com/2018/01/08/hap… https://t.co/PaXZpKHZza 7 months ago
    • RT @IVDAust: @MedDevLegal Australian IVD Companies may also be affected by this... 8 months ago
    • The notified body bottleneck in implementing EU #MDR and #IVDR becoming a problem for #medicaldevices manufacturers medtech.pharmaintelligence.informa.com/MT121869/Exper… 8 months ago
    • RT @mr_mag_online: Advocaten @MedDevLegal @axonlawyers @twobirdsNL @HoyngRokh blij met komst medicijnautoriteit EMA naar Amsterdam https:/… 8 months ago
    • Working on @AdvaMedUpdate workshop on implementation of the EU #MDR and #IVDR Vital for US #medicaldevices companies advamed.org/events/new-eu-… 8 months ago
    • A tsunami of EU #MDR and #IVDR implementation and guidance coming your way #medicaldevices medicaldeviceslegal.com/2017/11/25/a-w… https://t.co/1L1drMEKxT 8 months ago

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    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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