Medical devices (MDR, IVDR)

As of May 26, 2021, the Medical Devices Regulation (MDR), EU No 2017/745, and as of May 26, 2022, the In Vitro Diagnostic Medical Devices Regulation (IVDR), EU No 2017/746 are imposed. The regulations replace some of the old EU directives concerning medical devices.

To conduct a clinical investigation or a performance study 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 human biological samples, regulated by the Biobanks Act (2023:38), are included in the study, a biobank application with approval by the biobank custodian is required.

With these regulations, assessments of applications and notification for clinical investigations and performance studies of medical devices are jointly coordinated by the Swedish Medical Products Agency, the Swedish Ethical Review Authority and the Regional Biobank Centres (RBCs).

The RBC submits an opinion to the Swedish Ethical Review Authority that includes considerations regarding the subject information and the informed consent form, and to the Swedish Medical Products Agency concerning other issues.

At present, the RBCs has assignments from all regional biobanks, which means that a RBC will assess documentation relating to biological samples and give an opinion for all applications/notifications where newly taken samples are established in a regional biobank and where existing samples are released from, remain in or is to be established in a regional biobank. The opinion from the RBC is included when the request for information is sent to the sponsor. The assessment results in a national decision.

Due to the new process, all assessments, statements, complements of information, approval, and the establishing of biobank agreements are carried out faster than before.

When biobank samples are included

In cases where newly collected biobank samples are included in the clinical investigation or performance study of a medical device, it needs to be clear who is to be the responsible biobank principal. If the sponsor does not have its own biobank in Sweden and wishes to use the region’s biobank, it is recommended that the sample collection is established in one responsible biobank, even if the collection of sample takes place in several different regions.

The sponsor is responsible for contacting a biobank in one of the participating regions early in the process, with a request if the biobank can be responsible for the sample collection. Regardless of if the responsible biobank belongs to a region or not, the sponsor is responsible for ensuring that document T7a is completed and signed by the concerned biobank’s biobank custodian. T7a is then used to notify regions where biobank samples are newly collected that a biobank within another principal will establish and be responsible for these samples.

The biobank custodian at the responsible biobank is responsible for sending T7a to the biobanks in each concerned region before the collection of samples can start. If samples will be established in a biobank in the same region where they are collected, T7a does not need to be used.

A biobank application is required for studies where newly collected samples will be established in and/or existing samples will be released from, remain in or be established in a regional biobank. The biobank application is then submitted to the RBCs on the same day as the application/notification for clinical investigation or performance study is submitted to the Swedish Medical Products Agency. When the biobank application is assessed by a RBC prior to the approval of the clinical investigation/performance study the process is accelerated. As a result, a potential completion of information for the biobank application can be handled during the assessment 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 investigations or performance studies of medical devices”.

For more information:

Regulatory framework for clinical investigations of medical devices | Swedish Medical Products Agency (lakemedelsverket.se)

The process of the biobank application in clinical investigations or performance studies of medical devices

Prior to submitting the biobank application

  1. Contact the RBCs early in the process, preferably at the planning stage, for guidance regarding the biobank application by e-mailing kliniskaprovningar@biobanksverige.se.
  2. A) Responsible biobank belongs to a region – Complete forms T1.1. If the application includes existing samples, form L1a and/or L1b is also to be completed.

    B) Responsible biobank does not belong to a region – Newly collected samples could be established directly in the responsible biobank by the biobank custodian and according to the biobank’s own routines. No biobank application should be sent to RBC. If existing samples should be released from a region’s biobank, form L1a and/or L1b should be completed.

    All forms can be found on Biobank Sweden’s document page under the toggle menu called “Research – Documents in English”.

  3. Send the un-signed biobank application to kliniskaprovningar@biobanksverige.se at the same time as the application/notification for clinical investigation/performance study 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 must go through the Swedish Medical Products Agency or the Swedish Ethical Review Authority.

If any completion of information is needed for 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. If existing samples are to be released, RBC prepares the form for release of samples (T1.2).
  2. After the approval of the clinical investigation/performance study, RBC sends the cover page (TY5) with the final assessment, instructions and the application form (T1.1/T1.2/L1a/L1b) to the sponsor with the request to amend potential considerations.

Approval of the biobank application

Following the approval of the clinical investigation/performance study from the Swedish Medical Products Agency and the Swedish Ethical Review Authority, the sponsor must send all signed biobank applications to the RBC or the biobank, according to the instruction in the cover page, so that authorised representatives of the biobank can make a decision.

The following applies for assessed biobank applications:

  • The sponsor is recommended to send the signed biobank application to the 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 the RBC shall be appended to the biobank application when sent to the biobank of the healthcare principal or the RBC for a decision.
  • The number of original copies of every application that must 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 the 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 signed by sponsor and approved and signed by an authorised representative of the biobank.

Applications outside the scope of the MDR or IVDR

This process does not apply to clinical investigations of a medical device or a performance study of a medical device for in vitro diagnostics, that do not fall within the scope of the MDR or IVDR, and where the research principal has submitted an application directly to the Ethical Review Authority in their application system Ethix. The Medical Products Agency provides guidance on this:

Handling of applications and notifications | Swedish Medical Products Agency (lakemedelsverket.se)

For these applications, the biobank application should instead be sent directly to the biobank in question according to the following description:

Document K2.1 (form selector)

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

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