Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)
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| Document information | |
|---|---|
| Reference | EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 |
| Validity area | EU |
| Scope(s) | MD ; IVD |
| Document name | COMMISSION IMPLEMENTING DECISION (EU) 2022/729 |
| Version / Revision | 11-May-2022 |
| Status | Current |
| Document type | Regulatory requirement |
| Language(s) | EN |
| Description | 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 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 â Unit 1.3.0 |
| Scope | MD |
| Document part | (9) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Harmonised standard, Quality management system, Risk, Medical device |
Content
COMMISSION IMPLEMENTING DECISION (EU) 2022/729
of 11 May 2022 â 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.
