First standards harmonised under MDR/IVDR

In only a trickle rather than the desired flood, the first five standards to be harmonised under the MDR and IVDR have been published in the Official Journal of the European Communities (OJEC).

Four of the standards are identified for both MDR and IVDR, covering sterilization, and one has been identified for medical devices only, this being the recently published EN ISO 10993-23 standard covering tests for irritation.

Industry waits with bated breath for more to arrive!