Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1: 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=1.2.7 | ||
|scope=MD | |||
|doc_part=Article 62 | |||
Paragraph 1 | Paragraph 1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00201-Cli-eSt ++ TAG-00340-Req-nfo ++ TAG-00200-Cli-gKl ++ TAG-00196-Con-odu ++ TAG-00155-Med-Med | |||
|tags_display=[[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00200-Cli-gKl|Clinical evaluation]], [[Glossary:TAG-00196-Con-odu|Conformity assessment]], [[Glossary:TAG-00155-Med-Med|Medical device]] | |||
|comment=General requirements for clinical investigations to demonstrate device conformity | |||
|content=General requirements regarding clinical investigations conducted to demonstrate conformity of devices | |||
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General requirements regarding clinical investigations conducted to demonstrate conformity of devices | |||
1. Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes: | 1. Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes: | ||
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(c) to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device. | (c) to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device. | ||
}} | |||
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 1.2.7 |
| Scope | MD |
| Document part | Article 62
Paragraph 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical investigation, Requirements, Clinical evaluation, Conformity assessment, Medical device |
Content
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
1. Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:
(a) to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2, and achieves the performance intended as specified by its manufacturer;
(b) to establish and verify the clinical benefits of a device as specified by its manufacturer;
(c) to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
