Bereits in der kommenden Woche soll das EU-Parlament die neue EU-Medizinprodukte-Verordnung (Medical Device Regulation, MDR) in zweiter Lesung verabschieden. Damit wird der gesamte Rechtsrahmen für Medizinprodukte neu gestaltet, erläuterte Ingrid Tolle vom Bundesgesundheitsministerium auf einer MedInform-Konferenz am 30. März 2017 mit rund 100 Teilnehmern in Bonn. MedInform ist der Informations- und Seminarservice des BVMed. Die MDR tritt vermutlich im Mai 2017 in Kraft und gilt nach einer dreijährigen Übergangsfrist ab Mitte 2020. Die Übergangsfrist ist aufgrund der umfangreichen neuen Anforderungen an die Benannten Stellen, an die klinische Bewertung von Medizinprodukten, durch neue Pläne- und Berichtspflichten oder das neue EUDAMED-/UDI-Datenbanksystem allerdings bnniu nihxlzun.
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