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It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the Ethical Review Authority and in many cases also from the Medical Products Agency.

Applying for an ethical review

If you are planning to carry out research on living and/or deceased persons, on biological material from humans, or research that involves handling sensitive personal data, you must apply for and have your research ethically reviewed and approved by the Ethical Review Authority. In order to formulate your application as well as possible, it is important to know the starting points for the ethical review.

According to the Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460), research may only be approved if:

  • it can be conducted with respect for human dignity
  • human rights and fundamental freedoms have been taken into account, at the same time as consideration has been paid to the interest in the development of new knowledge through research
  • the well-being of humans has been considered and given priority ahead of the needs of society and science
  • the risks it may entail to the health, safety and personal integrity of participants are outweighed by the scientific value
  • it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence

You can read more about research ethics in medical research in the Declaration of Helsinki.

Application for ethical review is done via the Ethical Review Authority's website. On the website you can also find answers to commonly asked questions, guidance for application and information about how to write the information for study participants.

An ethical review is carried out only once the application is complete, which means that the form has been filled in correctly, the fee has been paid and all information requested has been submitted. The administration time for the Ethical Review Authority is approximately 60 days, information on fees for ethics review can be found on the authority's website.

If your study needs to be approved by the Swedish Medical Products Agency, the process for ethical review has been affected by new EU regulations for both clinical trial on medicinal products and medical devices. Find out what applies to your study in the sections "Special rules for medicines and medical devices" further down the page.

Information about the Ethical Review Act

Information on research ethics in connection with medical research in the Declaration of Helsinki

Application for ethical review and guidance for the design of a research plan, the Swedish Ethical Review Authority (in Swedish) External link.

Answers to frequently asked questions about the application, the Swedish Ethical Review Authority (in Swedish) External link.

Information on how data for study participants should be designed, the Ethical Review Authority (in Swedish) External link.

Information on fees for ethics review, the Swedish Ethical Review Authority (in Swedish) External link.

Generic templates for conducting clinical studies, Apotekarsocietet's section for Clinical Studies in collaboration with LIF and the Swedish Medical Products Agency (in Swedish) External link.

Research projects in which study participants are irradiated

There are special regulations for medical exposure to ionizing radiation, such as X-ray examinations. These become applicable in clinical studies where participants are exposed to ionizing radiation.

More information regarding rules for clinical studies in which study participants are exposed to ionizing radiation

Application for access to biobank samples

In order to conduct research on samples covered by the Biobanks Act, an approved biobank application is required. Human biological samples that are taken in health care and are traceable to the individual sample donor are covered by the Biobanks Act. Biobank samples are taken for care, diagnostics and treatment or for clinical research and can be anything from fluids such as blood, serum, plasma and saliva to stool samples and tissue samples such as biopsies, tumors and organs.

Approval from the Swedish Ethics Review Authority is always required when biological samples are taken for research, regardless of whether they are covered by the Biobanks Act or not. If you are unsure whether samples in the study are covered by the Biobanks Act, you can contact the region's biobank coordinator or a Regional Biobank Center (RBC) for advice.

The biobank application is sent to the region's biobank coordinator or to an RBC for review and approval. You can also get advice in connection with the biobank application or to get tips when designing research person information and the parts of the application for ethical review that are about tests.

New EU regulations for clinical trials on medicinal products and medical devices also affect the process for applying for biobanks. Read more under the sections "Specific rules for medicines and medical devices" further down the page.

Forms and instructions for biobank applications and contact information for, among others, biobank coordinators and RBC, Biobank Sweden (in Swedish) External link.

Finding out what applies for handling of personal data

The General Data Protection Regulation (EU) 2016/679 regulates whether and how personal data may be handled for research purposes. The legal entity that handles the personal data in its operation and who decides on what data is to be handled, and what the data shall be used for is responsible for the handling of personal data (personal data controller).

Before starting your clinical study, you should find out what applies for handling of personal data within your organisation. If there is a personal data officer, this is a suitable person to contact.

Information about the handling of personal data is available on the Swedish Data Protection Authority’s website External link, opens in new window..

Register your study before the start of the study

The fact that it is easy to find information about clinical studies is important from both an ethical and a scientific perspective. In research on humans, studies must be registered before they begin and results reported so that both researchers and the general public can follow what the research leads to. These are requirements and guidelines set by the World Health Organization (WHO) and the Declaration of Helsinki. Many scientific journals in the medical field have also introduced study registration as a publication requirement. In addition, some healthcare regions have their own requirements for registration.

Requirements and guidelines, World Health Organization External link.

Requirements and guidelines, Declaration of Helsinki External link.

About publication requirements, International Committee of Medical Journal Editors (ICMJE) External link.

Guidelines and further information on student registration, the Swedish Research Council External link.

Agreement on conducting clinical studies

In Sweden, healthcare, universities, colleges and the pharmaceutical industry collaborate with the aim of developing the conditions for conducting clinical studies.

The agreement reached sets out the conditions for the collaboration, which includes clinical trials on medicinal products and on medical devices, in Sweden.

Documents, Sweden's municipalities and regions (SKR) (in Swedish) External link.

Documents, LIF - the researching pharmaceutical companies in Sweden (in Swedish) External link.

Specific rules for medicinal products or medical devices

There are special rules to comply with regarding clinical studies with medicinal products or medical devices.

Specific rules for medicinal products

Applying for authorisation for clinical trials on medicinal products

Clinical trials where medicinal products are studied can be covered by the definition of clinical trials, and special permission is required. This can apply to both studies that are performed on new medicinal products under development, but also studies on medicinal products that are already approved for sale. The purpose can be both commercial and academic.

For guidance on whether your planned clinical trial is subject to authorisation, a guide has been published on the Swedish Medical Products Agency's website.

Find out whether your clinical trial is subject to authorisation, the Swedish Medical Products Agency External link.

Apply according to old or new regulations

On 31 January 2022, a new EU regulation on clinical trials on medicinal products apply. During a transitional period, it will be possible to apply for and carry out studies both in accordance with the old EU Directive 2001/20 / EC with associated national legislation and in accordance with the new EU Regulation EU 536/2014 (also called Clinical Trials Regulation, CTR).

More information about transitional rules, the Swedish Medical Products Agency External link.

For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC

It will be possible to apply according to the old regulations until 31 January 2023. In that case, an application must be sent to the Swedish Ethics Review Authority via their own system Ethix and a separate application must be sent to the Swedish Medical Products Agency. You'll get two separate decisions from these two authorities.

For details on the application for authorisation for clinical trials on medicinal products in accordance with the old regulations, the Swedish Medical Products Agency External link.

For details on the application for authorisation for clinical trials on medicinal products in accordance with the old regulations, the Swedish Ethics Review Authority (in Swedish) External link.

For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014

If an application is to be made in accordance with the new regulations, the application must be submitted via the EU portal CTIS (Clinical Trials Information System). Both the Swedish Medical Products Agency and the Swedish Ethical Review Authority will then have access to this application. Coordination takes place and the applicant will only receive one decision that applies to both authorities.

For details on the application for a permit for clinical trials on medicinal products according to the new EU regulation, the Swedish Medical Products Agency External link.

Includes your clinical trial on medicinal products biobank samples

If your clinical trial on medicinal products includes biobank samples, an approved biobank application is required. According to the new application routine, the biobank application must be sent to kliniskaprovningar@biobanksverige.se in parallel with the application being sent to CTIS.

Biobank application according to the new EU regulation, Biobank Sweden (in Swedish) External link.

If you during the transition period, 31 January 2022 - 31 January 2023, choose to apply according to the old EU directive, another routine applies.

Application routine during the transition period according to the old EU directive, Biobank Sweden (in Swedish) External link.

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


Notification and application to the Swedish Medical Products Agency
Most of the clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency. In most cases the Swedish Medical Products Agengy coordinates the review with the Swedish Ethics Review Authority. This means that it it the sponsor who submits the application documents that are to be examined by the Swedish Ethical Review Authority when they are attached to the notification or application that is sent to the Swedish Medical Products Agency. Find out more under the page Planning on this website. External link.

It is only clinical investigations of CE-marked medical devices, where the study participants are not exposed to further invasive or strenuous procedures that are not coordinated as above. That is, here it is still the principal investigator who applies for the ethical review directly to the Ethics Review Authority via the application portal Ethix.

What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?
Whether it is an application or notification the requirements for the documentation to be submitted for review are the same. The dossier excits of an application form and mandatory appendices which are submitted electronically. The mandatory appendices to the application form are defined in each authority's application form (see links below).

Appendices such as trial handbook, written information to be provided to study participants and the clinical trial plan is recommended to be designed in accordance with ISO 14155: 2020, read more under the section Planning. The appendices must, among other things, show that the test product is ready for a medical technical clinical trial, ie that the product meets the general requirements for safety and performance apart from the aspects covered by the study.

General requirements for security and performance

What happens to my notification or application?
Depending on which permit procedure is applied, the authorities' review will be differently extensive and run according to different deadlines. The most comprehensive review procedure takes 45 days after a valid application is received.

For medical technical clinical trials that have been reported to the Swedish Medical Products Agency, the Swedish Ethical Review Authority makes a decision within 30 days (no further decision is received from the Swedish Medical Products Agency).

For medical technical clinical trials applied for to the Medical Products Agency, and the product is:

  • invasive in class IIa or IIb or a product in class III, the Swedish Medical Products Agency and the Swedish Ethical Review Authority make a coordinated decision within 45 days
  • class I or non-invasive product in class IIa or IIb, a validation notice from the Swedish Medical Products Agency must be awaited and thereafter the Swedish Ethical Review Authority makes a decision within 40 days.

Information about the authority's review and permit procedures, the Swedish Medical Products Agency's website External link.

Information about the authority's review and permit procedures, the Swedish Ethical Review Authority's website External link.

If the trial will take place in several countries, there will be possibile to have a coordinated permit procedure within the EU. The coordinated procedure is being implemented in the EU. To investigate the possibility of a coordinated procedure, contact the Swedish Medical Products Agency.

Investigate the possibility of a coordinated licensing procedure, the Medical Products Agency's website External link.

Includes your clinical investigation of medical device biobank test
If your clinical trial includes a biobank test, an approved biobank application is required.

The Regional Biobank Center is also part of the coordinated process to facilitate the establishment of the biobank agreement. A Biobank application must always be submitted to the Regional Biobank Center at the same time as the application for clinical trials is sent to the Medical Products Agency.

Application routine for medical devices, Biobank Sweden's website (in Swedish) External link.

Medical devices for in vitro diagnostics, EU regulation IVDR


Registration and application to the Swedish Medical Products Agency
The new IVD legislation introduces requirements for applications for a permit and a notification obligation to the Swedish Medical Products Agency for certain types of clinical performance studies of in vitro diagnostic products. Read more under the section Planning.

Clinical performance studies that are subject to notification to the Swedish Medical Products Agency are such studies that involve:

  • treatment-indicating diagnostics performed using residual sample material
  • that a CE-marked diagnostic product is studied within the framework of the intended purpose, but the study involves further invasive or strenuous procedures for the subject.

Clinical performance studies that are subject to application to the Swedish Medical Products Agency are such studies that involve:

  • an interventional study of clinical performance
  • that surgically invasive sampling is performed and where the procedure is performed solely for the purposes of the study
  • that further invasive procedures or other risks for the subjects are performed, even if these have nothing to do with the sampling procedure
  • treatment-indicating diagnostics where samples / materials are taken specifically for the study.

These types of performance studies must be reported or applied to the Swedish Medical Products Agency, which coordinates the review with the Swedish Ethical Review Authority. This means that application documents that are to be examined by the Swedish Ethics Review Authority are attached to the notification or application that is sent to the Swedish Medical Products Agency.

However, many performance studies will continue to be able to be carried out without either notification or application to the Swedish Medical Products Agency. These must then apply for ethical review to the Swedish Ethical Review Authority via the Ethix application portal.

What should be sent to the Swedish Medical Products Agency and the Swedish Ethical Review Authority, respectively?
Regardless of whether it is an application or notification, the requirements for the documentation to be submitted for review are the same and are set out in Chapter I of Annex XIV of IVDR. Application form and mandatory appendices are submitted electronically.

Instructions for registration and application, the Swedish Medical Products Agency's website External link.

Application form and instructions for application, the Swedish Ethical Review Authority website (in Swedish) External link.

Appendices such as trial handbook, written information to be provided to study participants and the clinical performance study plan is recommended to be designed in accordance with ISO 20916: 2019, read more under the section Planning. The appendices must, among other things, show that the trial product is ready for a medical technical clinical trial, ie that the product meets the general requirements for safety and performance apart from the aspects covered by the study.

General requirements for safety and performance

What happens to my registration or application?
Depending on which permit procedure is applied, the authorities' review will be different in scope and run according to different deadlines. The most comprehensive review procedure takes 45 days after a valid application is received.

For clinical performance studies reported to the Swedish Medical Products Agency, the Swedish Ethical Review Authority makes a decision within 30 days (no further decision is received from the Swedish Medical Products Agency).

For clinical performance studies applied to the Swedish Medical Products Agency, the Swedish Medical Products Agency and the Swedish Ethical Review Authority make a coordinated decision within 45 days.

Information about the Swedish Medical Products Agency's review and permit procedures External link.

Information on the Swedish Ethics Review Authority's review and permit procedures (in Swedish) External link.

Includes your medical technology clinical trial biobank test
If your clinical trial includes a biobank test, an approved biobank application is required. The Regional Biobank Center is also part of the coordinated process to facilitate the establishment of the biobank agreement. A Biobank application must always be submitted to the Regional Biobank Center at the same time as the application for clinical trials is sent to the Swedish Medical Products Agency.

Application routine for medical devices, Biobank Sweden's website (in Swedish) External link.