News - July 1, 2019
The European Commission asks for new standards in line with MDR/IVDR requirements.
The European Commission is calling the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to propose revision to current standards and new ones to be in line with the coming Medical Devices and In Vitro Diagnostics Regulations’ requirements. The requested focus area includ amongst others on sterilization, biological evaluation, packaging, aseptic processing, clinical investigation and labelling.
More information on the European Commission’s website https://ec.europa.eu/docsroom/documents/36104?locale=en.