This week, the European Commission has initiated a public feedback period regarding proposed changes to regulations governing medical devices and in vitro diagnostics. The focus of this initiative includes significant updates to cybersecurity requirements within these regulations.
The suggested revisions aim to simplify existing EU rules, thereby reducing administrative burdens while ensuring high standards for public health and patient safety. The Commission has already received approximately 450 responses to its earlier call for evidence and has now published its complete proposal.
The regulations under review include (EU) 2017/745 concerning Medical Devices and Regulation (EU) 2017/746 related to In vitro Diagnostic Medical Devices. These rules oversee more than 2 million medical technologies across Europe, which play an essential role in healthcare by facilitating the diagnosis and treatment of various diseases.
As discussions progress, the Commission will engage with the European Parliament and European Council to refine the legislative framework further.