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Biobank samples in clinical trials/performance studies

The new EU regulations leads to changed processes when you perform a clinical trial/performance study that includes biobank samples. On this page we explain all you need to know to apply for access to biobank samples in Sweden.

Important information

The following will apply when performing a clinical trial or performance study according to the EU regulations CTR, MDR and IVDR:


  • The biobank application may only be approved after the clinical trial/ performance study has been approved.
  • The biobank agreement is not valid until after the application and any appendices are approved and signed by authorised representatives of the biobank.

Visit the pages above for specifics regarding each regulation.

Please note, in this general description of clinical trials the term “application” is used and includes the process concerning MDR and IVDR where a “notification” is made.

See also:

Pricelist for clinical trials

Documents and forms
Documents and forms

All forms can be found on Biobank Sweden’s document page under the toggle menu called “Clinical trials/performance studies”.


Biobank Sweden can help you with guidance or answer questions regarding how to apply for biobank samples for clinical trials.

Contact us at Do this as soon as possible, preferably before beginning your trial to reduce the risk of a delayed start.

Latest update: 2024-02-01