Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | ||
| | |module=1 | ||
| | |unit=1.2.8 | ||
|scope=MD | |||
|doc_part=Annex XV | |||
Chapter I | Chapter I | ||
Section 2 | Section 2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00201-Cli-eSt ++ TAG-00203-Cli-lin ++ TAG-00338-Met-odi ++ TAG-00177-Ben-koB ++ TAG-00175-Per-ist | ||
|tags_display=[[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00338-Met-odi|Methodology]], [[Glossary:TAG-00177-Ben-koB|Benefit-risk]], [[Glossary:TAG-00175-Per-ist|Performance (device)]] | |||
|comment=Clinical investigation methods and planning basis | |||
= | |content=2. Methods | ||
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2. Methods | |||
2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex. | 2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex. | ||
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2.8. The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings. | 2.8. The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | MD |
| Document name | Regulation (EU) 2017/745 - Medical Device Regulation |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.8 |
| Scope | MD |
| Document part | Annex XV
Chapter I Section 2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical investigation, Investigation plan, Methodology, Benefit-risk, Performance (device) |
Content
2. Methods
2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex. […] 2.4. Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population. Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV. […] 2.6. The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device. The endpoints shall be determined and assessed using scientifically valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant. […] 2.8. The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings.
