Question for written answer E-002182/2020 to the Commission Rule 138 Lucia Vuolo (ID), Matteo Adinolfi (ID), Annalisa Tardino (ID), Vincenzo Sofo (ID), Francesca Donato (ID), Alessandro Panza (ID), Stefania Zambelli (ID), Anna Bonfrisco (ID), Gianna Gancia (ID) Subject: Checking and punishing producers of unsuitable PPE medical devices, and the coordinating role of the Commission Italy and other EU Member States are fighting the coronavirus. The first line of defence from the virus is Personal Protective Equipment (PPE). Face masks, single-use gloves and surgical gowns are essential for the safety of health personnel, patients and the general population. Every country is buying PPE, including from non-EU manufacturers. The technical requirements of PPE are well- known and mandatory. Recently, however, doctors, nurses and the public have apparently been receiving, also from non-EU countries, unsuitable PPE bearing no identification labels. In view of the above, can the Commission answer the following questions: Even though the ‘guidelines on a medical devices vigilance system’ are ‘not legally binding’, in order to protect the health of Europeans what is the Commission doing to prevent the entry into the EU, or production in the EU, of unsuitable devices? The guidelines state that the Commission ‘shall ensure that appropriate coordination and cooperation is put into place between the competent authorities’ of the Member States. In order to provide a high level of protection for the health and safety of patients and citizens, is the Commission aware, and is it informing the national authorities, of those manufacturers which have been producing/selling unsuitable PPE? Would it be possible to create a ‘ban list’ of companies which have failed to comply with EU health standards? Supporter1 1 This question is supported by a Member other than the authors: Mara Bizzotto (ID) PE650.949v01-00.