Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7.: 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=2.2.1 | ||
|scope=MD | |||
|doc_part=Annex XV | |||
Chapter III | Chapter III | ||
2. ; 7. | 2. ; 7. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00245-Spo-ten ++ TAG-00111-Agr-chr ++ TAG-00046-Ser-sSc ++ TAG-00203-Cli-lin ++ TAG-00201-Cli-eSt | |||
|tags_display=[[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00111-Agr-chr|Written agreement]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]] | |||
|comment=Sponsor obligations: agreements and oversight of contractors | |||
|content=OTHER OBLIGATIONS OF THE SPONSOR | |||
| | |||
| | |||
= | |||
OTHER OBLIGATIONS OF THE SPONSOR | |||
[...] | [...] | ||
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[…} | […} | ||
}} | |||
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 2.2.1 |
| Scope | MD |
| Document part | Annex XV
Chapter III 2. ; 7. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor responsibilities, Written agreement, Serious adverse event, Investigation plan, Clinical investigation |
Content
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 as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner. [...] 7. The Sponsor shall prepare a clinical investigation report which includes at least the following:
— Cover/introductory page or pages indicating the title of the investigation, the investigational device, the single identification number, the CIP number and the details with signatures of the coordinating investigators and the principal investigators from each investigational site.
[…}
