ARTICLE SUMMARY:
In this week’s roundup: Europe publishes its first harmonized standards to the Medical Device and IVD Regulation, CMS reverses course on inpatient-only and surgical center policies, Singapore 3D-printing guides, and more from Australia, Canada, and the US.
Top Pick: EU Standards
At long last, harmonized EU MDR/IVDR standards:
Long-awaited publication. Regulatory affairs departments will get a little bit of a load off now that the European Commission has finally published the first standards to be officially harmonized to the Medical Device and IVD Regulations. Until now, manufacturers couldn’t presume compliance to any of the regulations’ provisions based on conformity to a global standard, requiring extra rationalization and paperwork to meet the grade with notified bodies. Now, at least for the five standards harmonized to MDR and the four harmonized to IVDR, companies can enjoy a streamlined process. Four of the standards harmonized to each regulation address sterilization processes and requirements. And one additional standard harmonized to the MDR is a relatively new standard addressing tests for irradiation as part of biological evaluations of devices. This a baby step in a process that will ultimately require hundreds of existing and new standards to be harmonized. The effort was delayed due to challenges the Commission ran into in getting EU standards bodies to accept its overall request to harmonize standards to the new regulations. (See “EU Retries Standards Request and Defines ‘State of the Art,’ Market Pathways, April 21, 2021.)
