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Cortex - Life Sciences Insights

| 1 minute read

Single-use medical devices' reprocessing and further use to be permitted in Portugal

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. 

In accordance with the 2015/1535 notification procedure, and for the duration of the standstill period (set to end on 23.12.2021), the Portuguese Government cannot approve this legislative proposal, thus enabling the European Commission and other Member States to examine the proposed draft and to respond appropriately, notably if found to create barriers to the free movement of goods or to the free provision of Information Society services or to EU secondary legislation.


medical devices, europe, regulation-devices, portugal