Clinical investigation of medical devices according to Medical Devices Regulation (MDR)

As of May 26, 2021, the Medical Devices Regulation (MDR), EU No 2017/745, is imposed. The new regulation replaces some of the old EU directives concerning medical devices. For more information go to Regulatory framework for clinical investigations of medical devices | Swedish Medical Products Agency (lakemedelsverket.se)

To conduct a clinical investigation of medical devices in Sweden an approval from the Swedish Medical Products Agency or the Swedish Ethical Review Authority is needed depending on what type of authorization procedure that will be practiced. In cases where biobank samples, covered by the Biobanks in Medical Care Act, are included in the investigation, a biobank application with approval by the biobank custodian is required.

With the new regulation, assessments of applications and notification for clinical investigations of medical devices is to be coordinated between the Swedish Medical Products Agency, the Swedish Ethical Review Authority and Regional Biobank Centre (RBC). Due to the new process, assessments, statements, complements of information, approval, and the establishing of agreements are carried out faster.

The biobank application

In cases where biobank samples are included in a clinical investigation of medical devices, a biobank application approved by the biobank custodian is required. Something that is new, as a result of the new regulation (EU No 536/2014), is that the biobank application shall be submitted to a Regional Biobank Centre (RBC) the same day as the application for clinical investigation is submitted. When the biobank application is assessed by RBC prior to the approval of the clinical investigation the process is sped up. Potential completion of information for the biobank application can be handled during the assessment in CTIS, and the establishment of an agreement can be executed faster. Read more about the application process for access to biobank samples under the headline “The process of the biobank application in clinical investigation of medical devices”.

The process of the biobank application in clinical investigation of medical devices

Prior to submitting the biobank application

  1. Contact RBC early in the process, preferably at the planning stage, for guidance regarding the biobank application by mailing kliniskaprovningar@biobanksverige.se.
  2. Complete forms T1 and T1a. If the application includes existing samples, form L1a and/or L1b is also to be completed. All forms can be found on Biobank Sweden’s document page under “Research – Documents in English”.
  3. Send the un-signed biobank application to kliniskaprovningar@biobanksverige.se at the same time as the application for clinical investigation of medical devices is submitted to the Swedish Medical Products Agency.

Assessment of the biobank application

  1. RBC validates and assesses the biobank application. If the application includes existing pathology/cytology samples, a feasibility assessment will be made by a pathologist.

Please note: RBC will only give guidance regarding the biobank application directly to the sponsor. All communication regarding the clinical investigation shall go through the Swedish Medical Products Agency or the Swedish Ethical Review Authority.

If completion of information is needed for the application of clinical investigation and/or the biobank application

  1. RBC sends the potential request for completion of information regarding the biobank application, including deadline, to the sponsor by e-mail.
  2. Sponsor submits the completion of information regarding the biobank application.

Final assessment of the biobank application

  1. RBC prepares the agreement (T1b and/or T1c ­– not to be completed by sponsor).
  2. RBC informs if the multicentre principle is applicable and if there is a need to establish an N4 with private care givers.
  3. RBC sends the cover page (TY5) with the final assessment, instructions, the main application form (T1) and the proposal for the agreement (T1n and/or T1c) to the sponsor with the request to amend potential objection.

Approval of the biobank application

Following the approval of the clinical investigation from the Swedish Medical Products Agency and the Swedish Ethical Review Authority the sponsor shall send all signed biobank applications to RBC or the biobank, according to the instruction on the cover page, so that authorised representative of the biobank of the healthcare principal or the head of RBC can make a decision. The following applies for assessed biobank applications:

  • The sponsor is recommended to send the signed biobank application to RBC or the biobank as soon as possible or at the latest, three weeks after the approval of the clinical investigation.
  • The cover page from RBC shall be appended to the biobank application when sent to the biobank of the healthcare principal or RBC for decision.
  • The number of original copies of every application that shall be sent depends on the number of signing parties.
  • Remaining documentation does not need to be enclosed but are sent to the appropriate biobank by RBC.
  • If any modifications are made to the biobank application after the assessment, this must be stated in a separate covering letter addressed to the representative that is going to make the final decision ­– this may prolong the process.
  • Please note: the biobank agreement does not come into force until the biobank application and all appendices, if any, are approved and signed by an authorised representative of the biobank of the healthcare principal and/or the head of RBC.
FAQ

What is new with the regulation regarding clinical investigation of medical devices (MDR), (EU No 2017/745)?

Please note that, there are additional FAQs on our main page for clinical trials

For questions, contact

kliniskaprovningar@biobanksverige.se

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