Version detected , Modified +25 −26§
no amending act named
Explanation, written by a model and checked against the cited text
In paragraph 1, the list of provisions applying to PMCF investigations changed how Articles 75, 76 and 77 are referenced, listing them together as 'Articles 75, 76 and 77' instead of separately as 'Article 75, Article 76, Article 77'.
The reference to Article 80(5) was expanded to also include Article 80(6).
Cited: Art. 74, v1 (external, EUR-Lex) · Art. 74, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version 32017R0745 → this version, detected 12 August 2026 02017R0745-20170505
Article 74
Clinical investigations regarding devices bearing the CE marking
1. Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (PMCF investigation), and where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 73. The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification. Points (b) to (k) and (m) of Article 62(4), Article Articles 75, Article 76, Article 76 and 77, and Article 80(5) and (6), and the relevant provisions of Annex XV shall apply to PMCF investigations.
2. Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply.