Devices that are part of clinical investigations (investigational devices) and systems in accordance with Article 22(1) and 22(3) of Regulation (EU) 2017/745.
The Swedish Medical Products Agency’s regulations laying down provisions supplementary to the EU Medical Devices Regulation
The draft regulations impose registration requirements on systems.
The draft regulations ease requirements where clinical investigations are carried out for purposes other than those referred to in Article 62(1) of Regulation (EU) 2017/745.
The mutual recognition clause is deemed to have no relevance, since the requirements under the regulations are imposed on operators with links to Sweden, not directly as regards the marketing and use of goods.