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Medical Devices Regulation: Portugal issues a notification pursuant to Directive (EU) 2015/1535

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Portugal has recently initiated the 2015/1535 notification procedure of the decree-law ensuring the implementation in the internal legal order of the Medical Devices Regulation.

The legislative proposal includes provisions on the following main topics: identification of competent authorities and their powers; activities relating to devices (manufacturing, custom manufacturing, manufacturing and use by and in health institutions, use, codification, distribution, marketing and advertising); notified bodies; surveillance; common provisions concerning general obligations; inspection and supervision rules, and penalty regime applicable in the event of infringement of the Regulation and the Decree-Law.

The notification was received on 01.03.2021, and the respective standstill date will end on 02.06.2021. For the duration of the standstill period, the Portuguese Government cannot adopt the decree-law in question, thus enabling the European Commission and other Member States to examine the proposed draft and to respond appropriately, notably if the draft is found to create barriers to the free movement of goods or to the free provision of Information Society services or to EU secondary legislation.

Portugal has informed the Commission of the draft decree-law to be adopted in respect of the MDR's implementation, initiating a standstill period for the examination of the provisions intended to be introduced for medical devices.

Tags

medical devices, regulation-devices, europe

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