The European Union Parliament implements new in vitro diagnostics and medical devices regulation
The European Union (EU) Parliament has endorsed the new Regulation on In vitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR). The official transition date will be around the 1st of June, 20 days after the new laws are published in the Official Journal. The Regulations will be fully implemented in three and five years for medical devices and in vitro diagnostics, respectively.
For the in vitro diagnostic sector, there is a need for secondary legislation and European best practice guidance for the Regulation to be successfully implemented within five years. For the medical device sector, this Regulation brings in all the best practices from the existing Commission guidance. The industry has pointed out some priority areas for both sectors:
- In vitro diagnostics: classification, conformity assessment, clinical evidence and early availability of notified bodies.
- Medical devices: agreed harmonized approaches, clarity, updated clinical evaluation requirements, new scrutiny process and early availability of notified bodies