Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8)
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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 | IVD |
| Document part | (8) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Harmonised standard, Quality management system, Risk, IVD |
| Comment | EU implementing decision on harmonised standards for quality management and risk management (IVD devices) |
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
(8) In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 are listed in one act, the reference of harmonised standard EN ISO 14971:2019 and of its amendment should be included in Implementing Decision (EU) 2021/1195.
