MHRA & FDA to explore In Vitro Diagnostics regulations in the EU & USA

Top Quote SMi Group's 3rd In Vitro Diagnostics conference will take place in London on the 14th & 15th June 2017. End Quote
  • (1888PressRelease) April 04, 2017 - Aimed at Managers/Heads and Directors of Regulatory Affairs, In Vitro Diagnostics, Clinical Affairs and Quality Assurance, IVDs 2017 will provide regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape.

    Through a series of presentations from handpicked industry experts and Notified Bodies, the 2017 event will prepare attendees for the challenging times ahead and how to comply with regulatory requirements to ensure direct access to market ensuring the continued growing demand for use and innovation of IVDs over the next decade and beyond.

    In line with this, SMi has announced that the MHRA & the FDA will both be presenting key discussions about In Vitro Diagnostics regulations within the EU & USA.

    On day one Adrian Bartlett, Medical Devices and EU Policy Manager from MHRA will provide attendees with his presentation on 'A closer look at the new EU regulations on in vitro diagnostic (IVD) devices'. He will highlight the main changes occurring as well as discuss the key challenges from a competent authority perspective and discuss how to comply with timelines.

    Alberto Gutierrez, Deputy Director of IVD, Office of In Vitro Diagnostic Device Evaluation and Safety from FDA will be presenting on day two of the conference on 'In Vitro Diagnostic Regulation in USA'. Alberto will explore: In-vitro diagnostic classification, pre-market and post-market requirements in USA, product life cycle: modifications and new product development and prescription vs over the counter requirements.

    MHRA and FDA will be joined by LNE/GMED North America, LRQA, TÜV SÜD, Ortho Clinical Diagnostics, DEKRA and more…

    A full roster of speakers and their presentations can be found at

    In Vitro Diagnostics
    14-15 June 2017
    Holiday Inn Kensington Forum

    Contact Information:
    For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale ( @ ) smi-online dot co dot uk
    For delegate queries contact Adolis Miniauskas on +44 (0) 20 7827 6744 / aminiauskas ( @ ) smi-online dot co dot uk
    To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick ( @ ) smi-online dot co dot uk

    About SMi Group:
    Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at

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