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Metrology for medical devices – towards a European harmonised approach

21 October 2019 Berlin Adlershof

Workshop scope

The workshop aims to create an international interdisciplinary exchange of ideas and approaches between legislators, regulators and manufacturers in the field of medical devices with a measurement function.

It will concentrate on two main aspects:

- The harmonisation of the different national approaches towards ensuring that instruments conform to EU (and            other) legislation. This is particularly important in the field of medicine

- The measurements needed for medical devices, and how they feed into market surveillance

 

 

Workshop topics

Topics to be discussed at the workshop include:

  • EU and national medical device legislation (MDD, MDR, national legislations)
  • International standards versus common specifications
  • Regulations for placing on the market versus national regulation for devices in operation (periodic verification)
  • Development of common verification strategies for medical devices in operation
  • Classical metrology versus medical metrology
  • Establishment of a European network for medical devices with a measuring function to underpin the harmonisation of requirements

Additionally, a round table and panel discussion will be held.

Background to EU medical device regulation

Registration

Venue

In case of questions and for further information, please contact MedMet2019@ptb.de


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