«Increasing digitisation and greater interconnection have seen a rising number of malicious cyber activities around the world. To respond to these increasing threats, the European Commission has introduced new legislation and regulation on cybersecurity that will impact the medtech sector.»

«On 17th January, the NIS 2 Directive entered into force – updating the EU’s rules on the security of network and information systems (NIS Directive). The new legislation covers medium and large entities from sectors considered critical for the economy and society. The scope of the NIS 2 Directive has been widened to cover manufacturers of medical devices and in vitro diagnostic medical devices (IVDs).»

«NIS 2 classifies businesses falling within its scope in two categories – ‘essential’ and ‘important’ entities. The manufacturers of medical devices and IVDs are classified as ‘important’ entities. The Directive also categorises businesses manufacturing medical devices that are considered to be critical during a public health emergency, as ‘essential’.»

Article written by CHRIS WHITEHOUSE



Med Tech News