Q&A concerning the practical aspects of Manufacturers’ Obligation to Inform in case of Interruption or Discontinuation of Supply of certain Medical Devices and IVDs
Medical Devices, Interruption of Supply, Discontinuation of Supply Elisabethann Wright Medical Devices, Interruption of Supply, Discontinuation of Supply Elisabethann Wright

Q&A concerning the practical aspects of Manufacturers’ Obligation to Inform in case of Interruption or Discontinuation of Supply of certain Medical Devices and IVDs

The European Commission has also published a Q&A document on the practical aspects of the notification obligations provided in Article 10a of the MDR and the IVDR concerning interruption in supply or discontinuation of supply of certain medical devices and how these should be fulfilled.  health in one or more EU Member States

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Article 10a Decison Tree
Medical Devices, Manufacturers, Interruption of Supply, Discontinuation of Supply Elisabethann Wright Medical Devices, Manufacturers, Interruption of Supply, Discontinuation of Supply Elisabethann Wright

Article 10a Decison Tree

‍Article 10a of the MDR governs obligations imposed on manufacturers and the competent authorities of EU Member States in case of interruption or discontinuation of supply of certain devices. The European Commission has developed an Article 10a Decision tree. The purpose of the Decision tree is to provide support to manufacturers

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