Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 â 5: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | ||
| | |module=6 | ||
| | |unit=6.4.2 | ||
|scope=IVD | |||
|doc_part=Article 77 | |||
Paragraph 4 â 5 | Paragraph 4 â 5 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00231-Per-ung ++ TAG-00037-End-ung ++ TAG-00017-Spo-die ++ TAG-00142-Mul-ent ++ TAG-00253-Rep-att | |||
|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00037-End-ung|Trial end]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00142-Mul-ent|Multicentre trial]], [[Glossary:TAG-00253-Rep-att|Reporting timeline]] | |||
 | |comment=Sponsor reporting at end of performance study to all Member States | ||
|content=4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study. | |||
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4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study. | |||
5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII. | 5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII. | ||
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Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification. | Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification. | ||
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Latest revision as of 13:50, 16 July 2026
| 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 6 â Unit 6.4.2 |
| Scope | IVD |
| Document part | Article 77
Paragraph 4 â 5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Trial end, Sponsor, Multicentre trial, Reporting timeline |
Content
4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study.
5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII.
The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 69.
Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification.
