EU medical device approval safety assessment

Backgrounders & Fact sheets

This is a period of tremendous flux and uncertainty in the medical device industry. Changes to the current medical device approval process are being considered by regulators in both the US and EU. The FDA is currently reviewing the US 510(k) process to improve the approval & monitoring of medical devices in the US, while the European Commission (EC) is also exploring changes to the Medical Device Directive (MDD) and IVD Directive (IVDD) to increase potential robustness of the EU process.