| Theme | Clinical investigation |
| Target Audience | Sponsors (recital 49) |
| Products concerned | MD |
| Documents mentioned |
MDR (EU) 2017/746 Chapter VI Directive 90/385/EEC Directive 93/42/EEC ISO 14155 :2020 |
Aimed primarily at sponsors of clinical investigations, MDCG 2021-6 provides clarifications in the form of questions and answers on the conditions for carrying out these different types of investigations under Regulation (EU) 2017/745.
REV1 :
- 19 questions/answers have been added:: Q 2, Q 4, Q 5, Q 14, Q 15, Q 16, Q 17, Q 18, Q 25, Q 26,Q 27, Q 28, Q 39, Q 41, Q 43, Q 44, Q 48, Q 49, Q 50.
- 11 answers have been updated: Q 7 (former Q 4), Q 9 (former Q 6), Q 11 (former Q 7), Q 12 (former Q 8), Q 21 (former Q 11), Q 24 (former Q 14), Q 30 (former Q 15), Q 32 (former Q 17), Q 34 (former Q 19), Q 35 (former Q 20), Q 36 (former Q 21)
- 2 questions have been updated :Q 40 (former Q 24), Q 45 (former Q 26)
- Concerning the appendices to this document
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- the legend of Appendix I has been updated
- Annex II has been amended to bring it into line with the terminology used in the DM Regulation.
- A new annex, Annex III, has been added.
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