We are pleased to announce that the University Clinical Centre of the Medical University of Warsaw (UCC MUW), with legal support from our Law Firm, has obtained a positive decision from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP) authorising the introduction of barrier helmets for ventilation of patients with COVID-19 on the premises of UCC MUW.
The product is used for oxygen therapy and respiratory support for patients with respiratory failure in the acute course of COVID-19 disease. Thanks to the technology used, the helmet is an excellent alternative to high-flow nasal oxygen therapy (HFNO) and non-invasive ventilation (NIV).
The third wave of the pandemic and the related sudden increase in the number of patients requiring hospitalisation made it necessary to take quick action to implement an innovative solution. The involvement of the Management, the entire team of doctors and employees of UCC MUW, as well as scientists from the Medical University of Warsaw, with legal support from our Law Firm, resulted in the issuance of a positive (final and binding) decision by the President of ORMP within just 3 working days from the submission of the application.
The legal basis for UCC MUW’s application was the provision of Article 15(3) of the Act of 20 May 2010 on Medical Devices (Journal of Laws of 2020, item 186, as amended), which allows a healthcare provider to request the authorisation referred to in Article 59(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the EU L 117 of 05.05.2017, p. 1, as amended), to place on the market and put into service a specific device for which the conformity assessment procedures have not been carried out.
The University Clinical Centre of the Medical University of Warsaw was successfully represented in proceedings before the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products by Mateusz Niewiński, attorney-at-law.
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