The New In Vitro Diagnostic Device Regulation (IVDR) - Frequently asked questions

IVDR - FAQsWith the new IVDR expected to be published in Q2 2017, regulatory affairs professionals and device manufacturers are now seeking clarification on how to implement the new requirements within their organizations.

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Our experts:

Nick Baker

Image - Nick Baker

Nick Baker is the Technical Manager for Medical Devices at LRQA, and is responsible for conformity assessment activities and certification under the In Vitro Diagnostics Devices (IVD) Directive. As a recognized expert within the IVD regulatory arena, Nick has dedicated his entire career spanning over 25 years to specializing within the in vitro diagnostics industry, where he has strong expertise along different parts of the supply chain, from designing and producing in vitro diagnostic tests to scheme management. Nick is an active contributor to the development of IVD regulations through a strong network comprising key regulatory bodies and working groups. He currently chairs the Notified Bodies Recommendation Group, and is a member of both the IVD working group for Notified Bodies as well as the Medicines and Healthcare Products Regulatory Agency (MHRA) External Strategy Group for the IVD Revision. He is also a Fellow of the Institute of Biomedical Sciences.

Prior to joining LRQA in 2001, Nick was a scheme manager at BSI, where he was responsible for conformity assessment activities of ocular devices under the Medical Devices Directive (MDD). Nick’s earlier experience included seven years at Wellcome Diagnostics (later Murex Diagnostics), where he gained significant experience in the design and production of immuno-assays for infectious diseases.

Ian Carmichael

Image - Ian Carmichael

Ian 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.