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 81 – Implementing acts

The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter as regards the following:
(a) harmonised electronic forms for the application for clinical investigations and their assessment as referred to in
Articles 70
⁠
and
78
⁠
, taking into account specific categories or groups of devices;
(b) the functioning of the electronic system referred to in
Article 73
⁠
;
(c) harmonised electronic forms for the notification of PMCF investigations as referred to in
Article 74(1)
⁠
, and of substantial modifications as referred to in
Article 75
⁠
;
(d) the exchange of information between Member States as referred to in
Article 76
⁠
;
(e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in
Article 80
⁠
;
(f) the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in
Article 80
⁠
;
(g) uniform application of the requirements regarding the clinical evidence or data needed to demonstrate compliance with the general safety and performance requirements set out in
Annex I
⁠
.
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in
Article 114(3)
⁠
.

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.