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