Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634
    Linkedin

    THE NEW EU REGULATION 2017/745 ON MEDICAL DEVICES

    Understanding the Regulation and its impact on Industry

    The EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical devices industry. Beyond the familiar framework of the Medical Devices Directive 93/42 based on general requirements for safety and performance, harmonized standards, risk classification, the new Regulation introduce novel requirements in key areas such as stronger Notified Body Oversight, improved General Safetyand Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance.

    The Regulation also introduces a new responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors. The Regulation also brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.

    For the industry, it is just the right moment to get a detailed understanding of the new requirements and understand how to prepare for the end of the transition period in May 2020.

    Date: 12-13 June 2019
    Time: 09:30 am – 6:00 pm
    Venue: Vienna, Austria
    Cost: Early bird: € 1570* (until 15-05-2019)
                Ordinary: € 1780*
                Freelance – Academy – Public Administration: € 890*
                * For Italian companies: + 22% VAT
                The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate

    READ MORE & SIGN UP

    Registration offline
    Fill in the registration form (last page of the event brochure) and email it to maraclaudia.algarotti@lsacademy.com and she will process the booking at a 15% discount.

    Registration online
    Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.

    CONTACT
    For any further question feel free to contact Mara Claudia Algarotti maraclaudia.algarotti@lsacademy.com