Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 â 3: Difference between revisions
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| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | ||
| | |module=1 | ||
| | |unit=1.2.7 | ||
|scope=IVD | |||
|doc_part=Article 58 | |||
Paragraph 1 â 3 | Paragraph 1 â 3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00231-Per-ung ++ TAG-00235-Int-stu ++ TAG-00340-Req-nfo ++ TAG-00105-Sam-eEn | |||
|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00235-Int-stu|Interventional performance study]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00105-Sam-eEn|Sample collection]] | |||
 | |comment=Additional requirements for performance studies involving subjects | ||
|content=Additional requirements for certain performance studies | |||
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Additional requirements for certain performance studies | |||
1. Any performance study: | 1. Any performance study: | ||
| Line 58: | Line 27: | ||
3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. | 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. | ||
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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 1.2.7 |
| Scope | IVD |
| Document part | Article 58
Paragraph 1 â 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Interventional performance study, Requirements, Sample collection |
Content
Additional requirements for certain performance studies
1. Any performance study:
(a) in which surgically invasive sample-taking is done only for the purpose of the performance study;
(b) that is an interventional clinical performance study as defined in point (46) of Article 2; or
(c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,
shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.
2. Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority.
3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review.
