Specific rules for medical devices

Please note that as from 26 May 2021, new rules for clinical studies involving medical devicesexternal link will apply.

What shall be archived?

Please contact the information owner for information about what is to be archived in your particular study. In general, the sponsor of a study involving medical devices requiring a permit shall archive items such as application documents for the permit to conduct the study, information about the product characteristics and risk management documentation. The sponsor shall also archive data in the form of CRFs, summary raw data files, data analyses conducted and result reports. All principal investigators in the study shall archive trial files and source data generated at the own trial location. Unless otherwise has been specifically approved by the regulatory authorities, the investigator shall only provide pseudonymised information to the sponsor, and never information that discloses the study participants’ identity, such as signed consent forms or code keys. More information on the documents to be held by the investigator and sponsor respectively following conclusion of the study is available in ISO 14155 Annex E.

The investigator shall then archive their documentation in readable format within the own organisation. There is no statutory regulation of how long the investigator’s documentation in a medical device study shall be archived; instead, this follows from the rules applicable to the operation the investigator works in. However, the main rule is that the archiving period is never shorter than ten years. The sponsor and investigator may also agree on a longer archiving period if suitable.

The sponsor shall archive their documentation for no less than five years after manufacture of the product has ended. For implants, the documentation shall be archived for 15 years after manufacture has ended.