In addition to the amendment of the (informative) Annexes Z, corrections and editorial revisions were included however, there were no normative changes to DIN EN ISO 13485:2021 compared to DIN EN ISO 13485:2016. Implementing Decisions (EU) 2022//15 of 4 and 6 January 2022 respectively harmonised the new version of the standard for Regulations (EU) 2017//746. The standard DIN EN ISO 13485:2021 contains requirements for a quality management system for use by organisations that are required to demonstrate their ability to provide medical devices and related services - with the aim of continuously meeting applicable regulatory requirements and customer requirements.įollowing the entry into force of Regulations (EU) 46 on medical devices and in vitro diagnostic medical devices respectively, it was necessary to replace the European Annexes Z of EN ISO 13485, which represented the relationship between sections of the standard and EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC respectively.Īnnexes Z have been redrafted on the basis of the current EU regulations on medical devices and in vitro diagnostic medical devices, respectively, so that the relationship between sections of the standard and Regulations (EU) 46 is now presented. In December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN ISO 13485.
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