Skip to content
Gallery
EU MDR
Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
Share
Explore
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations

Article 74 – Clinical investigations regarding devices bearing the CE marking

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 75
⁠
,
Article 76
⁠
,
Article 77
⁠
,
Article 80(5)
⁠
and the relevant provisions of
Annex XV
⁠
shall apply to PMCF investigations.
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.

Want to print your doc?
This is not the way.
Try clicking the ⋯ next to your doc name or using a keyboard shortcut (
CtrlP
) instead.