The Council has published on February 22, 2017 the last consolidated texts regarding the MD and IVD new Regulations. These can be considered now as the final versions.
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 Article 11 regarding the liability for the European Authorized Representative has been maintained despite our efforts towards the EU Commission.
