At Last: New EU MDR Regulations Near Final Approval

After two decades of work, the EU’s new medical device and in vitro regulations are nearing their final approval stretch.

The European Council is set to vote on the regulations on March 7, and the European Parliament will vote on March 20. If passed, the regulations could become effective as early as May. Manufacturers would then have three years to comply with the MDR and five years to comply with the IVDR.

The two documents, which total 566 and 477 pages respectively, completely revamp the EU’s existing regulatory framework.