Medical Device: from a Directive (MDD) to a Regulation (MDR)
A “medical device” is any instrument, appliance, equipment, software, reagent, material or other item intended for use by the manufacturer on humans for one or more medical uses specificat
The Covid-19 is impacting also the timelines for the MDR readiness. EU commission is evaluating to postpone the implementation of 1 year. This can be considered an opportunity for all the stakeholders (Manufacturer, Authorized Representative, Importer, Distributor, Suppliers, Notified Body, Competent Authorities, European Commission) to deeply evaluate the transition from the current MDD to the 745/2017/UE (MDR) and 746/2017/UE (IVDR), with all the challenges and difficulties, and consequently optimize the transition.
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