IVDR Webinar - Overview of changes & priorities initiated by the new IVDR requirements

The new In Vitro Diagnostic Device Regulation (IVDR) will replace the existing In Vitro Diagnostic Device (IVD) Directive 98/79/EC. The Regulation is  currently in the final stage of development and are expected to be published towards the end of Q1 2017.

In January 2017, experts from LRQA will be delivering two webinars to discuss the current status of the new Regulations, the transition period for manufacturers and the expected ‘Entry into Force’ of the regulations. LRQA will present a comprehensive overview of the key changes which will affect all Medical Device and In-Vitro Diagnostic Medical Device manufacturers, as well as the priorities for the different authorities.

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IVDR Webinar Speakers

Nick Baker, LRQA Technical Manager – IVD Medical Devices

Image - Nick BakerNick has worked with LRQA for more than 15 years. As LRQA’s Technical Manager for IVD Medical Devices, he is responsible for the evaluation and assessment of technical documentation and certification decisions. He is the Chair of the Notified Body Recommendation Group and a member of Notified Body IVD working group, as well as a speaker at Informa and Q1 conferences on regulatory issues.

With more than 27 years’ experience in Medical Devices, Nick has prior worked as Scheme Manager for IVDs at BSI. He has extensive experience in IVD industry and was responsible at Anagen for managing a laboratory for routine production of hormone immunoassays and for viral immunoassays as a Team Leader at Murex Diagnostics.

Nick has knowledge of clinical chemistry and infectious disease, production and design of immuno-assays, and process validation. He holds a BSc in Biochemistry & Physiology from the University of Westminster and a MSc in Medical Biochemistry from Brunel University.

Ian Carmichael, MSc, FIBMS - IVD Technical Specialist

Image - Ian CarmichaelIan Carmichael joined LRQA in 2011 as the IVD Technical Specialist. Ian is responsible for managing the batch verification process for high-risk reagents, reviewing Design Dossiers and Technical Files for new products and re-approvals. He is LRQA’s product expert for blood grouping reagents, and specialist reviewer for IVD Directive Annex II List A Reagents, Medical Device Software as well as Blood Glucose Monitoring Systems.

Ian stared his career as a Biomedical Scientist within the NHS and then spent over 20 years in the manufacture of in vitro diagnostic reagents, holding various positions in internationally operating organisations ranging from Quality Control Scientist to Director of Quality and Regulatory Affairs. During this time, Ian has gained a thorough understanding and extensive implementation experience of the regulatory requirements for worldwide registration of Medical Devices.