The BRCA1-like test: New EU-wide regulation for in vitro diagnostic medical devices
HRD tumors
MAY
The BRCA1-like test is an in-house developed and used diagnostic test to identify patients with HRD tumors. On May 2022, the European Union’s In Vitro Diagnostic Regulation (IVDR) will come into force, and before that time a conformity assessment of the in vitro diagnostic medical device is necessary to meet the requirements and comply with the more stringent regulation [