Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 â 7: 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=1 | ||
| | |unit=1.5.4 | ||
|scope=IVD | |||
|doc_part=Article 66 | |||
Paragraph 6 â 7 | Paragraph 6 â 7 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00231-Per-ung ++ TAG-00059-Reg-lat ++ TAG-00017-Spo-die | ||
|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00059-Reg-lat|Regulatory submission]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | |||
 | |comment=Information requests during performance study assessment | ||
|content=6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. | |||
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6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. | |||
7. The sponsor may start the performance study in the following circumstances: | 7. The sponsor may start the performance study in the following circumstances: | ||
| Line 53: | Line 19: | ||
(b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts. | (b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts. | ||
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Latest revision as of 13:49, 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 1 â Unit 1.5.4 |
| Scope | IVD |
| Document part | Article 66
Paragraph 6 â 7 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Regulatory submission, Sponsor |
Content
6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received.
7. The sponsor may start the performance study in the following circumstances:
(a) in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study;
(b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
