European Council Adopts New EU MDR, IVDR Regs

The EU’s new medical device and in vitro regulations took another step toward final approval March 7 when they were adopted by the European Council.

The final step in the EU’s adoption process is a vote by the European Parliament, which is expected in April.

The two regulations completely revamp the EU’s existing regulatory framework, raising standards for approving medical devices and IVDs, strengthening oversight of notified bodies by national authorities, improving the availability of clinical data, and setting out manufacturers' responsibilities for ensuring devices are safe and reliable.