Harmonisatie ISO 11607 met EU Verordening Medical Devices

Revision of EN ISO 11607, the guiding standard for medical device packaging, is progressing toward completion later this year. With many of the changes prompted by EU’s new Medical Device Regulations (MDRs), could harmonization with the EU’s new law be next?
ISO Technical Committee 198 Working Group 7 met earlier this year in Copenhagen to resolve comments received after ISO 11607’s Draft International Standard (DIS) document was balloted last year. The next step will be to finalize a Final Draft Standard (FDIS) for final balloting this summer. While ISO/FDIS 11607 is intended to address the EU regulations, it is expected to be used outside EU markets, too (Packaging Digest, 11 April 2018).
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