Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
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| 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6 | MD | ANNEX XV Chapter III, 6 | EN | 6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII | MD | Annex VIII | EN | CLASSIFICATION RULES… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2 | MD | Annex XV
Chapter I Section 2 | EN | 2. Methods 2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7 | MD | Annex XV
Chapter II Section 1.7 | EN | DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION For investigational devices covered by Article 62, the sponsor shall draw up and s… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3. | MD | Annex XV
Chapter III 1. ; 3. | EN | OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. | MD | Annex XV
Chapter III 2. ; 7. | EN | OTHER OBLIGATIONS OF THE SPONSOR
[...] 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 | MD | Annex XV
Chapter III Paragraph 3 | EN | OTHER OBLIGATIONS OF THE SPONSOR 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical in… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 | MD | Annex XV
Chapter III Section 4 | EN | OTHER OBLIGATIONS OF THE SPONSOR 4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the invest… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 | MD | Article 109 Paragraph 1 | EN | Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Memb… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 | MD | Article 109 Paragraph 1 | EN | Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Memb… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 | MD | Article 2 Paragraph 1 - 3 | EN | Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, s… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12 | MD | Article 2 Paragraph 10 – 12 | EN | Definitions (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a spe… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14 | MD | Article 2 Paragraph 14 | EN | (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8 | MD | Article 2 Paragraph 4 – 8 | EN | (4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpos… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45 | MD | Article 2 Paragraph 45 | EN | Definitions (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46 | MD | Article 2 Paragraph 46 | EN | (46) ‘investigational device’ means a device that is assessed in a clinical investigation;… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62 | MD | Article 2 Paragraph 62 | EN | Definitions (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 | MD | Article 2 Paragraph 57 – 59 | EN | (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laborat… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 | MD | Article 2 Paragraph 64 – 66 | EN | (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-e… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 | MD | Article 51 | EN | Classification of devices 1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52 | MD | Article 52 | EN | Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1 | MD | Article 62 Paragraph 1 | EN | General requirements regarding clinical investigations conducted to demonstrate conformity of devices 1. Clinical investigations shall be designed,… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 | MD | Article 62 Paragraph 3 | EN | 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4 | MD | Article 62 Paragraph 3 & 4 | EN | 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 | MD | Article 62 Paragraph 4 | EN | 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 inv… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j) | MD | Article 62
Paragraph 4 (j) | EN | General requirements regarding clinical investigations conducted to demonstrate conformity of devices (j) the medical care provided to the subjects i… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1 | MD | Article 63 Paragraph 1 | EN | Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragrap… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2 | MD | Article 63 Paragraph 2 | EN | 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5 | MD | Article 63 Paragraph 3 – 5 | EN | 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7 | MD | Article 63 Paragraph 6 – 7 | EN | 6. The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be m… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64 | MD | Article 64 | EN | Clinical investigations on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informe… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65 | MD | Article 65 | EN | Clinical investigations on minors A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 | MD | Article 66 | EN | Clinical investigations on pregnant or breastfeeding women A clinical investigation on pregnant or breastfeeding women may be conducted only where, i… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 | MD | Article 68 | EN | Clinical investigations in emergency situations 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) a… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69 | MD | Article 69 | EN | Damage compensation 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation i… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1 | MD | Article 70 Paragraph 1 | EN | Application for clinical investigations 1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7 | MD | Article 70 Paragraph 6 – 7 | EN | 6. During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 | MD | Article 72 | EN | Conduct of a clinical investigation 1. The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance wit… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002 | MD | Article 72 Paragraph 3 – 4 | EN | Conduct of a clinical investigation 3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or i… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 | MD | Article 72 Paragraph 6 | EN | Conduct of a clinical investigation 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 | MD | Article 72 Paragraph 3 – 4 | EN | Conduct of a clinical investigation
[...] 3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponso… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 | MD | Article 72 Pragraph 2 | EN | Conduct of a clinical investigation 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 | MD | Article 72 Pragraph 5 | EN | Conduct of a clinical investigation 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investiga… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73 | MD | Article 73 | EN | Electronic system on clinical investigations 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an elect… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74 | MD | Article 74 | EN | Clinical investigations regarding devices bearing the CE marking 1. Where a clinical investigation is to be conducted to further assess, within the… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 | MD | Article 75 | EN | Substantial modifications to clinical investigations 1. If a sponsor intends to introduce modifications to a clinical investigation that are likely… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 | MD | Article 76 | EN | Corrective measures to be taken by Member States and information exchange between Member States 1. Where a Member State in which a clinical investi… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3 | MD | Article 76 Paragraph 3 | EN | Corrective measures to be taken by Member States and information exchange between Member States 3. Where a Member State has taken a measure referre… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 | MD | Article 77 | EN | Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. [...] In the event t… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5 | MD | Article 77 Paragraph 4 – 5 | EN | 4. If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation w… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7 | MD | Article 77 Paragraph 6 – 7 | EN | 6. The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report. In addition, the … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3 | MD | Article 77 Paragraph 1 – 3 | EN | Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4 | MD | Article 77 Paragraph 1, 3 & 4 | EN | Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has … |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5 | MD | Article 77 Paragraph 5 | EN | 5. Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 | MD | Article 80 Paragraph 1-2 | EN | Recording and reporting of adverse events that occur during clinical investigations
1. The sponsor shall fully record all of the following: (a) any… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 | MD | Article 80 Paragraph 3 | EN | 3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4 | MD | Article 80 Paragraph 4 | EN | 4. In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6 | MD | Article 80 Paragraph 5 – 6 | EN | 5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopt… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82 | MD | Article 82 | EN | Requirements regarding other clinical investigations 1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2 | MD | Article 87 Paragraph 1 – 2 | EN | Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices made available on the Union market, other than inves… |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5 | MD | Article 87 Paragraph 3 – 5 | EN | 3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal rel… |
