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BSI Consultants' Day - Medical Device Directives Revision and how it will affect your customers


GRS representatives received an exclusive invitation to attend BSI's Consultants' Day on 22 October 2013.  Interestingly this was also the same day for the EU Commission to vote on the new Medical Device Regulations - more about that later!

We all know that the world of Medical Device regulation is changing at an unprecedented rate, so GRS took this opportunity to hear directly from this Notified Body, BSI, what their thoughts and expectations were in relation to these changes.  The presentations were as follows:


  • Medical Device Directive changes and their impact on UK businesses (Neil Adams PhD, Operations and Delivery Director)
  • Ortho-spinal reclassification and what it means formanufacturers (Itoro Udolfio, Head of OrthoDental Team)
  • CE Marking & TeleHealth: Stay Mobile Through the Regulation Maze (Sharmila Gardner BSc, ARCS, MSc, PhD & Steve Ward HND, BSI Product Specialists/Technical Managers)
  • Unannounced Visits – Coming very soon (Vicky Medley, Head of QMS)
  • What the IVD Directive Changes Will Mean In Practice (Sue Spencer, Head of IVD)
  • A practical approach to clinical evaluation that fulfills the future EU regulation expectations (Dr Marie Eve Cluzel, PhD, Senior Consultant, NAMSA Clinical and Consulting Services)
  • Consultant Database: UK & Ireland (Damon Williams, Business Development Manager, Medical Devices UK and Ireland)


Unsurprisingly the key take home messages were:

  • "it's going to get tougher"
  • some of the things which currently should be implemented will definitely be enforced, for example, unannounced visits, clinical evaluations (particularly for Class I devices)
  • there's going to be a lot more work and companies need to start working towards compliance now


The Consultants' Day is a new initiative for BSI and assuming positive feedback from attendees, they will be running more in the future.  From what the Directors of GRS heard in the breaks, this initiative has been well received and we'd all like to see this continue for the long-term.  Well done BSI!


Author: Greer Deal, Director of Global Regulatory Services