| 2017/745_AnnexI _ II_III_ IV_ V_ VI_ VII_ VIII_IX_X_XI_XII_XIII_XIV_XV_XVI_XVII | ||||||||||||||
Article 81
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| (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).
1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) and Article 62(6).
2. In order to protect the rights, safety, dignity and well-being of subjects and the scientific and ethical integrity of clinical investigations not performed for any of the purposes listed in Article 62(1), each Member State shall define any additional requirements for such investigations, as appropriate for each Member State concerned.