{"id":7574,"date":"2022-07-04T12:00:19","date_gmt":"2022-07-04T10:00:19","guid":{"rendered":"http:\/\/www.epitype.de\/?p=7574"},"modified":"2023-07-04T10:21:32","modified_gmt":"2023-07-04T08:21:32","slug":"the-ivdr-in-vitro-diagnostic-medical-device-regulation","status":"publish","type":"post","link":"https:\/\/www.epitype.de\/en\/blog\/2022\/07\/04\/the-ivdr-in-vitro-diagnostic-medical-device-regulation\/","title":{"rendered":"The IVDR (In-vitro Diagnostic Medical Device Regulation)"},"content":{"rendered":"

The new IVDR<\/a> (In-vitro Diagnostic Medical Device Regulation) has been in force since 26 May. As a result, numerous companies have had to adapt their approval processes and internal procedures. The new regulations also present oncgnostics with new challenges. For example, the molecular biological cancer tests now fall into the second highest risk level. This means that significantly more requirements have to be met.\u00a0<\/strong><\/p>\n

What is the IVDR?<\/strong><\/h2>\n

The In Vitro Diagnostic Medical Device Regulation, IVDR for short, is an EU regulation that replaces the previous directive, the In Vitro Diagnostic Medical Device Directive (IVDD). Thus, the IVDR regulates the general safety and performance requirements of in vitro medical diagnostics devices within the European Union. Although the new regulation has already existed since 25 May 2017, it is now mandatory after a five-year transition period. For many companies, the new requirements mean major changes.<\/p>\n

The most important changes (selection)<\/strong><\/h2>\n

The introduction of the new IVDR is accompanied by several changes. The aim of the new regulation is to improve patient safety.<\/p>\n