AMDR appreciates Infarmed’s decree clarifying Portuguese policy for reprocessing and
remanufacturing of single-use medical devices (SUDs). Portugal’s history on this issue
is deep, having perhaps been the first EU Member State to adopt a regulatory paradigm
for SUD reprocessing (implementation Decision 939/2014) requiring compliance with
medical device manufacturer requirements (compliance with the essential requirements
of Annex I of the then MDD). AMDR views the new decree as a continuation of
Portuguese policy modified to reflect changes in EU law. . .

Click here for the full statement, and visit EC.Europa.EU for the proposed Portuguese regulations, as reported to the European Commission.