Medical devices, medical device accessories and non-medical products listed in Annex XVI to Regulation (EU) 2017/745.
Decree-Law ensuring the implementation in the internal legal order of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
The draft Decree-Law aims to lay down the rules necessary for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, accessories to medical devices and non-medical products listed in Annex XVI to that Regulation.
This legislative proposal includes 73 articles comprising, in summary: subject matter; scope of application; competent authority and its powers; specialised committee; activities relating to devices such as manufacturing, custom manufacturing, manufacturing and use by and in health institutions, use, codification, distribution, marketing and advertising; notified bodies; surveillance; some common provisions concerning general obligations, costs of acts and services and language; inspection and supervision rules, which include the penalty
regime applicable in the event of infringement of the Regulation and the Decree-Law itself; and final and transitional provisions.
Thus, this Act constitutes the legal framework which, at the same time, takes into account the necessary implementation of Regulation (EU) 2017/745 and the national paradigm as regards the entire circuit of devices, respecting the primacy of Community law and the protection of public health and safety of users/patients.
Key words: device, manufacture, coding, distribution, advertising, notification, registration, surveillance, supervision.