en
Dictionary:

Specific rules for medical devices

Medical devices are in the EU regulated by two categories that follow different regulations:

  • For medical devices, the EU Regulation on Medical Devices (MDR) applies. New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
  • For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New rules apply within the EU from 26 May 2022.

Medical devices, EU regulation MDR

What shall be archived?
In general, the sponsor of clinical investigations of medical devices 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 14155:2020, Annex E.

Standard ISO 14155:2020, SIS website External link.

How long should the study documentation be kept?
The investigator shall then archive their documentation in readable format. 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 ten years after the clinical investigation of the medical device has been conducted. If the product is launched on the market, the documentation must be kept for at least ten years after the last product has been sold on the market. For implants, the documentation shall be archived for 15 years.

Medical devices for in vitro diagnostics, EU regulation IVDR


What shall be archived?
In general, the sponsor of a clinical performance study or other performance studies must file, among other things, application documents for a permit to carry out the study, information about the product's properties and risk management documentation. The sponsor must also archive data in the form of completed CRFs, compiled raw data files, completed data analyzes and performance reports. All responsible testers in the study must archive the sample binder and source data generated at their own test site. Unless otherwise specifically approved by regulatory authorities, the examiner should only provide pseudonymous information to the sponsor, never information that reveals the identity of the study participants such as signed consent forms or code keys. More information about which documents must be available from the examiner and sponsor after completion of the study can be found in ISO 20916: 2019.

The standarden ISO 20916:2019 , SIS website External link.

How long should the study documentation be kept?
It is not regulated by law for how long the examiner's documentation in a clinical performance study or other performance studies must be preserved, but follows from the rules that apply to the activity to which the examiner belongs. As a general rule, the archiving period should not be shorter than ten years. Sponsors and testers can also agree on a longer filing period if appropriate. The examiner must archive his documentation in legible condition.

The sponsor must keep his study documentation for at least ten years after the clinical trial has ended, if the product is placed on the market, the documentation must be kept for at least ten years after the last product has been placed on the market.