Portugal initiated the 2015/1535 notification procedure of the decree-law establishing the rules applicable to the reprocessing and further use of single-use devices, following up Medical Devices Regulation Article 17 provision that allows such activities to be carried out where permitted by national law and insofar as compliance with the rules set down in the Regulation is guaranteed.
The draft legislative proposal contains the legal framework applicable to the above activities in Portugal, notably on public sector healthcare entities, corporate public hospitals of the National Health System, and entities that fulfil technical requirements to be defined by Infarmed. Main rules focus on notification requirements, obligations, and subcontracting, define prohibited reprocessing activities and create the framework applicable to administrative offenses. . .
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