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 73 – Electronic system on clinical investigations

The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:
to create the single identification numbers for clinical investigations referred to in
Article 70(1)
⁠
;
to be used as an entry point for the submission of all applications or notifications for clinical investigations referred to in
Articles 70
⁠
,
74
⁠
,
75
⁠
and
78
⁠
and for all other submission of data, or processing of data in this context;
for the exchange of information relating to clinical investigations in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in
Articles 70
⁠
and
76
⁠
;
for information to be provided by the sponsor in accordance with
Article 77
⁠
, including the clinical investigation report and its summary as required in paragraph 5 of that Article;
for reporting on serious adverse events and device deficiencies and related updates referred to in
Article 80
⁠
.
When setting up the electronic system referred in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council
(1)
⁠
as concerns combined clinical investigations of devices with a clinical trial under that Regulation.
The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
protection of personal data in accordance with Regulation (EC) No 45/2001;
protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure;
effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.
No personal data of subjects shall be publicly available.
The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
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.