View source for Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)

{{ReferenceData
|has_document=Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022
|module=1
|unit=1.3.0
|scope=MD
|doc_part=(9)
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00218-Har-päi ++ TAG-00288-Qua-nag ++ TAG-00176-Ris-erh ++ TAG-00155-Med-Med
|tags_display=[[Glossary:TAG-00218-Har-päi|Harmonised standard]], [[Glossary:TAG-00288-Qua-nag|Quality management system]], [[Glossary:TAG-00176-Ris-erh|Risk]], [[Glossary:TAG-00155-Med-Med|Medical device]]
|comment=EU implementing decision on harmonised standards for quality management and risk management for devices
|content=COMMISSION IMPLEMENTING DECISION (EU) 2022/729

of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

(9) The references of harmonised standard EN ISO 13485:2016 on quality management systems and its amendment EN ISO 13485:2016/A11:2021 are published by Implementing Decision (EU) 2021/1195.
}}