An Update on ISO 11607 and EU MDR

One of the objectives of the most recent revision of ISO 11607, "Packaging for Terminally Sterilized Medical Devices," published in February 2019, was to meet all packaging-related expectations outlined in the EU Medical Device Regulation, according to Thierry Wagner, global director, regulatory & standards – healthcare at DuPont Safety and convenor of the ISO TC198 Working Group 7. He spoke during the MD&M West 2020 presentation, “Global Medical Packaging Consensus Standards Development to Meet Regulatory Requirements.” The standard seeks to support the EU MDR’s general safety and performance requirements (GSPR) related to sterile packaging, he later told MD+DI, saying "the objective was to harmonize the European version EN ISO 11607, where the relationship with the MDR GSPRs would be outlined in a dedicated annex (Z)."
Wagner explained that "harmonized standards are developed by CEN, the European standard development organization under the frame of a formal mandate prepared by the EU Commission and approved by the EU member states. The EU Commission has published the first draft standardization request for the MDR in February 2019 followed by a second draft in June 2019 with additional requirements to be met by harmonized standards." However, while "the final MDR standardization request to CEN has not been published yet," Wagner added, "reviews of relevant standards have ...

Source: MDDI - March 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news