The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published Friday in the Official Journal of the European Union.
The European Council voted on the regulations March 7, and the European Parliament followed March 20. Manufacturers have three years to comply with the MDR and five years to comply with the IVDR once the new regulations go into effect (IDDM, April 10).
The two documents, totaling 566 and 477 pages respectively, completely revamp the EU’s existing regulatory framework.
Read the MDR here: www.fdanews.com/02-23-17-MDRegulations.pdf.
Read the IVDR here: www.fdanews.com/02-23-17-InVitroDiagnostics.pdf.