MedTech Summit 2016: Overview of Changes to Scope and Definition with the In Vitro Diagnostic Device Regulation (IVDR)


Almost four years since changes to the existing Medical Devices Directive (MDD 93/42/EEC) and In Vitro Diagnostic Devices Directive (IVDD 98/79/EC) were first proposed, the European Union is expected to finally agree on the text for both the Medical Device Regulations (MDR) and the In Vitro Diagnostic Device Regulations (IVDR) very soon.

Nick Baker, LRQA Technical Manager Medical Devices, will take the stage at the annual MedTech Summit 2016 to share a Notified Body's perspective on the latest developments with regard to the new IVDR, and what the changes mean for medical device manufacturers.

MedTech Summit 2016 - Nick Baker

Topics covered include:

  • Will the new definitions provide more clarity?
  • Are the definitions of the included items clear?
  • Comments on the inclusion of software, genetic tests, and companion diagnostics.

Through our extensive range of training and assessment services, LRQA is helping organisations worldwide remove the uncertainty associated with the changing medical regulatory landscape.  

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About 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 recognised expert within the IVD regulatory arena, Nick has dedicated his entire career spanning over 25 years to specialising 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 7 years at Wellcome Diagnostics (later Murex Diagnostics), where he gained significant experience in the design and production of immuno-assays for infectious diseases.