2021/0615/P
EC/EFTA
PT Portugal
  • S10S - Dispositifs médicaux
2021-12-23
2021-09-29

Single-use medical devices that can be reprocessed and reused.

Decree-Law allowing the reprocessing and reuse of single-use devices pursuant to Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 and laying down the sanctions regime applicable to their infringements

The draft Decree-Law aims to lay down the necessary rules for the reprocessing and reuse of single-use devices, in accordance with Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (hereinafter Regulation (EU) 2017/745) and Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 (hereinafter Regulation (EU) 2020/1207), and lays down the sanctions regime applicable to their infringements.

This legislative proposal contains 17 articles comprising, in short: subject matter and scope; the competent authority and its competences; entities; notifications; obligations; subcontracting, prohibitions; inspection and surveillance rules, which include the applicable penalty regime; and final provisions.
Thus, this Decree-Law constitutes the legal framework to be applied to the reprocessing and reuse of single-use medical devices in Portugal, taking into account the provisions of Regulation (EU) 2017/145, in particular Article 17.
Keywords: device, reprocessing, use, single, notification, obligation.