Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | ||
| | |module=2 | ||
| | |unit=2.3.2 | ||
|scope=MD | |||
|doc_part=Article 62 | |||
Paragraph 4 | Paragraph 4 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00201-Cli-eSt ++ TAG-00340-Req-nfo ++ TAG-00134-Eth-kom ++ TAG-00029-Inf-rte ++ TAG-00059-Reg-lat | ||
|tags_display=[[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00059-Reg-lat|Regulatory submission]] | |||
|comment=Conditions required before clinical investigation can be conducted | |||
|content=4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met: | |||
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4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met: | |||
(a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated; | (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated; | ||
| Line 73: | Line 39: | ||
(m) the requirements of Annex XV are fulfilled. | (m) the requirements of Annex XV are fulfilled. | ||
}} | |||
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 2 — Unit 2.3.2 |
| Scope | MD |
| Document part | Article 62
Paragraph 4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical investigation, Requirements, Ethics committee, Informed consent, Regulatory submission |
Content
4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
(b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
(c) the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;
(d) vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
(e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
(f) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;
(g) the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;
(h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
(i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;
(j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
(k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the clinical investigation;
(l) the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;
(m) the requirements of Annex XV are fulfilled.
