Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1
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| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | IVD |
| Document name | Regulation (EU) 2017/746 - in vitro diagnostic medical devices |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 â Unit 1.5.4 |
| Scope | IVD |
| Document part | Article 66
Paragraph 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Regulatory submission, Sponsor, IVD |
Content
Application for performance studies
1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article as âMember State concernedâ) accompanied by the documentation referred to in Sections 2 and 3 of Annex XIII and in Annex XIV.
The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV.
