The workshop will cover the Medical Device Regulation (MDR); an EU directive that sets binding and harmonised rules for placing medical devices on the market and encourages a coordinated approach to market surveillance.
In this context, two main aspects arise:
- the harmonisation of the different national approaches concerning the metrological verification of devices as part of market surveillance; and
- the harmonisation of the metrological requirements for conformity assessment and market surveillance.
The workshop aims to address these two aspects and create an international, interdisciplinary exchange of ideas and approaches between legislators, regulators and manufacturers in the medical devices field.
The event has been organised by the National Metrology Institutes, Physikalisch-Technische Bundesanstalt (PTB) and Český Metrologický Institut (ČMI), with additional support from the European Association of National Metrology Institutes (EURAMET).
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