View source for Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3

{{ReferenceData
|has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
|module=4
|unit=4.2.5
|scope=MD
|doc_part=Annex XV
Chapter III
Paragraph 3
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00271-Ret-Arc ++ TAG-00343-Doc-ten ++ TAG-00245-Spo-ten ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med
|tags_display=[[Glossary:TAG-00271-Ret-Arc|Sponsor record retention]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00155-Med-Med|Medical device]]
|comment=Sponsor obligation to keep documentation available
|content=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 investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.

Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
}}