Idea
During the idea stage, you investigate what is already known in the field, identify a knowledge gap and formulate the research question that the study will answer. The research question influences the type of study that needs to be conducted and the data that need to be collected.
- From an idea to a research question
- Health and medical care or clinical research?
- Compare your idea with previous research
- Search for clinical studies and scientific publications
- Search systematic assessments
- Search scientific knowledge gaps
- Investigate whether existing register data can be used
- Formulate the research problem and research question
- Specific requirements for medicinal products and medical devices
- If your idea or research question involves medicinal products
- Find out whether your idea involves a medical device
- Find out whether your idea involves an in vitro diagnostic medical device
- Related information about Advanced therapy medicinal products (ATMPs)
- Advanced therapy medicinal products (ATMPs)
From an idea to a research question
A research idea may arise from previous research or as a possible solution to a problem encountered in clinical practice. Before you begin planning a study, you need to investigate whether the idea is viable and how it relates to existing knowledge.
In healthcare, a research idea may involve:
- developing or improving working methods, treatments or products
- investigating a method or intervention that is already in use but for which the scientific evidence is insufficient
- evaluating whether an existing treatment can be used for another indication
By searching scientific literature, registers and databases, you can map the current state of knowledge, identify knowledge gaps and define the problem that the study will investigate.
Health and medical care or clinical research?
Health and medical care refers to measures taken to medically prevent, investigate and treat diseases and injuries. Healthcare must be provided in accordance with science and proven experience.
Provisions concerning healthcare are set out in legislation including:
- the Health and Medical Services Act (2017:30)
- the Patient Safety Act (2010:659)
- the Patient Act (2014:821)
Other regulations apply when conducting research. The requirement for science and proven experience does not apply to treatments being evaluated as part of a clinical study. On this website, you can find information about the requirements that apply when conducting a clinical study.
Compare your idea with previous research
By searching for scientific publications and information about ongoing and completed studies, you can compare your idea with previous research. The idea may, for example, concern a new method, treatment or product.
The review may show whether there are already:
- similar products, methods or treatments
- clinical data supporting the idea
- ongoing studies or development projects with a similar purpose
- systematic assessments in the field
- identified scientific knowledge gaps
Understanding the current state of research is important for avoiding unnecessary duplication and building on existing knowledge.
Search for clinical studies and scientific publications
Several databases provide information about ongoing and completed clinical studies and published research.
Clinical study databases
- WHO International Clinical Trials Registry Platform (ICTRP) External link.
Compiles information about registered studies from several international databases. - Clinicaltrials.gov External link.
A US database containing information about clinical studies from many different countries. It includes both ongoing and completed studies. - EU Clinical Trials, CTIS External link.
A European database for clinical trials of medicinal products under Regulation (EU) No 536/2014. - EU Clinical Trials Register External link.
A European register containing information about clinical trials of medicinal products under the previous EU Directive 2001/20/EC.
Scientific publication database
- PubMed External link.
A freely available database containing scientific publications in fields including medicine and health.
Search systematic assessments
Health Technology Assessment (HTA) is a systematic assessment of the available evidence for a medical method, technology or treatment.
An HTA may consider scientific, economic, organisational and ethical perspectives. The assessment is based on a systematic review of published research and may, for example, compare a new method or technology with an established method. Its purpose is to provide a basis for more evidence-based healthcare.
HTAs are conducted nationally by organisations including the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), and regionally by HTA organisations in several Swedish healthcare regions.
Search scientific knowledge gaps
A scientific knowledge gap is an area in which a method or intervention used in healthcare or social services has not been sufficiently evaluated.
SBU identifies scientific knowledge gaps based on sources including:
- SBU’s own reports
- national guidelines from the National Board of Health and Welfare
- other systematic literature reviews.
On SBU’s website, you can search identified knowledge gaps across many different fields. These knowledge gaps can provide ideas for research and help you assess where the need for new studies is greatest.
Identified scientific knowledge gaps, SBU website External link.
Investigate whether existing register data can be used
Government agencies and other public bodies maintain registers and population-based surveys that may contain data of value to clinical research. The data may have been collected for other purposes but may still be relevant to answering a research question.
Health data registers and national quality registers may, for example, be relevant to clinical studies.
Guide to accessing health data from Swedish healthcare regions
The procedures for applying for and obtaining access to health data differ between Swedish healthcare regions. Clinical Studies Sweden has therefore compiled a guide showing where to turn and how to request access to health data in each region.
Guide to requesting access to health data from a Swedish healthcare region (in Swedish)
National quality registers
Swedish healthcare has quality registers that have been developed in different fields to support the systematic and continuous development and assurance of the quality of care.
Data from quality registers can be used in research to:
- identify risk factors for disease and ill health
- follow up and evaluate the benefits and risks of medicinal products, treatments and other interventions
Support for using register data
Dataguiden.se provides information and support for researchers who want to use register data. It offers guidance on how to:
- identify relevant registers
- request access to data
- use data correctly and securely
Dataguiden.se, a service provided by the Swedish Research Council External link.
Formulate the research problem and research question
The research problem describes the problem or knowledge gap that the study will help to investigate. A clearly formulated research problem makes it easier to define the purpose and research question of the study.
The research question should clarify what the study will investigate. Once the question is sufficiently specific, you can begin to determine:
- which type of study is needed
- which study participants or materials are relevant
- which data need to be collected
- how the collected data will be analysed
The research problem and research question form the basis of the research plan or study protocol developed during the planning stage.
Points to consider during the idea stage
When developing your research idea, you need to clarify what the study will investigate, why it is needed and how the research question can be answered.
- What is already known in this field?
- What knowledge gap will the study help to address?
- What research question do you want to answer?
- What data or material do you need to collect?
- How could the study benefit patients, healthcare or society?
- How will the collected data be analysed?
Specific requirements for medicinal products and medical devices
If your research idea involves a medicinal product or medical device, specific regulations and processes apply.
Under the relevant headings below, you will find information about what to consider during the idea stage and how to determine whether the study may be subject to:
- the rules governing clinical trials of medicinal products
- the EU Medical Devices Regulation (MDR)
- the EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
Contact your regional node within Clinical Studies Sweden if you are unsure which regulations apply or need support in developing your research idea and planning the study.
If your idea or research question involves medicinal products
Clinical trials of medicinal products are governed by Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Clinical Trials Regulation, CTR).
If your study involves medicinal products, you need to determine whether it is classified as a clinical trial of a medicinal product that requires authorisation.
In Sweden, all clinical trials of medicinal products must be authorised before they can begin. Applications are submitted through the EU portal CTIS and reviewed by the Swedish Medical Products Agency and the Swedish Ethical Review Authority.
If the study is a non-interventional study, it does not need to be reviewed or authorised by the Swedish Medical Products Agency. Other requirements, such as ethical review, may still apply.
Find out whether your idea involves a medical device
Clinical investigations of medical devices are governed by the EU Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect on 26 May 2021.
What is a medical device?
A medical device may be an apparatus, instrument, implant, software or another product intended for a medical purpose. Medical purposes include diagnosing, preventing, monitoring, alleviating or treating disease, injury or disability in humans.
Unlike a medicinal product, a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means. Its function may, however, be assisted by such means. Products intended to support conception or to disinfect or sterilise medical devices are also considered medical devices.
The manufacturer determines the device’s intended purpose and specifies how it is intended to be used.
Who is considered the manufacturer?
You or your employer may be considered the manufacturer if you:
- develop a medical device
- use an existing device for an indication not specified by the manufacturer
- modify an existing medical device.
In these cases, you are responsible for determining whether the product falls within the definition of a medical device. If it does, you must comply with the MDR and other regulations governing clinical investigations of medical devices.
If you plan to use a commercially available product in your research, you can contact the manufacturer to find out whether the product is classified as a medical device.
If you are unsure whether it is a medical device
It can sometimes be difficult to determine whether a product you plan to use in your research is a medical device. Contact the Swedish Medical Products Agency for advice or contact your regional node within Clinical Studies Sweden.
The European Commission also publishes guidance on borderline products and software that qualifies as a medical device.
- Definition of a medical device in the EU Medical Devices Regulation, EUR-Lex website External link.
- Is is a medical device?, the Swedish Medical Product Agency's website External link.
- Guidance on qualification and classification of software: MDCG 2019-11, European Commission website External link.
Different types of medical devices
Medical devices in the EU are governed by different regulations depending on the type of device.
Medical devices under the MDR
The EU Medical Devices Regulation (EU) 2017/745 (MDR) came into effect on 26 May 2021.
Medical devices governed by the MDR are divided into risk classes I, IIa, IIb and III. Risk classification is influenced by several factors, including how invasive the device is and whether it is active, meaning that it supplies or exchanges energy with the human body.
In vitro diagnostic medical devices under the IVDR
In vitro diagnostic medical devices are governed by Regulation (EU) 2017/746 (IVDR). For more information, see the section Medical devices for in vitro diagnostics (IVDR).
Is the device ready for use in a clinical investigation?
Before a medical device can be used in a clinical investigation, it must meet the regulatory requirements for safety and performance to the greatest extent possible without being tested in humans.
This includes ensuring that:
- technical and biological safety assessments have been completed
- all risks have been minimised
- the remaining risks have been shown to be justified in relation to the expected clinical benefit.
For more information, see General requirements and harmonised standards further down on this page.
Clinical evaluation of the device
Manufacturers intending to CE mark a medical device must first carry out a clinical evaluation. The methodology for clinical evaluation is described in Annex XIV to the MDR.
In brief, the methodology involves systematically reviewing data from the scientific literature according to defined criteria. The results are documented in a written report.
The report must show whether the existing data demonstrate that the device meets the general safety and performance requirements or whether additional clinical investigations need to be conducted.
Methodology for clinical evaluation, Annex XIV to the Medical Devices Regulation External link.
Formulate a hypothesis or research question
To enable a medical device to reach its full potential in healthcare, the manufacturer should align the characteristics being evaluated with the needs and interests of the intended users.
Claims about the device’s safety and performance must be supported by clinical data. It may therefore be valuable to consult:
- clinical researchers in the relevant field
- intended users
- relevant patient or diagnostic groups
- representatives of the relevant clinical professions.
The risk management process and the results of the clinical evaluation help identify which aspects of the device require further investigation and which research questions the clinical investigation should answer.
The device’s stage of development also influences how the hypotheses should be formulated and whether the investigation should be exploratory, confirmatory or combine both approaches.
For more information about study design and statistical considerations, see the Planning and Analysis pages.
- Guidance - Clinical Evidence for Medical Software: MDCG 2020-1: European Commission website External link.
- Study design, chapter Planning
- Statistical considerations, chapter Analysis
Submit a notification or apply for authorisation for a clinical investigation
A clinical investigation of a medical device is a systematic investigation involving one or more study subjects, conducted to assess the safety or performance of a device.
A clinical investigation of a medical device must be submitted to the Swedish Medical Products Agency in one of the following ways:
- as a notification of a clinical investigation
- as an application for authorisation to conduct a clinical investigation.
The same documentation is required in both cases.
To determine whether your clinical investigation requires a notification or an application for approval, see the information on the Planning page on this website or visit the Swedish Medical Products Agency’s website.
- Plan your study, information on registration or permit required
- Notification and permission,The Medical Products Agency's website External link.
Follow Good Clinical Practice
The Swedish Medical Products Agency recommends that all clinical investigations of medical devices are conducted in accordance with the international standard ISO 14155:2026, Clinical investigation of medical devices for human subjects – Good clinical practice.
The purpose of ISO 14155:2026 is to:
- protect the rights, safety and well-being of study subjects
- ensure scientific rigour and reliable study results
- define responsibilities
- support the parties assessing whether a medical device meets the general safety and performance requirements.
Under an agreement between the Swedish Institute for Standards (SIS) and the Swedish Association of Local Authorities and Regions (SKR), employees in Swedish healthcare have free access to many standards, including ISO 14155:2026, on the SIS website.
ISO 14155:2026, SIS website External link.
General requirements and harmonised standards
General safety and performance requirements
The general safety and performance requirements, also referred to as the general requirements, are set out in Annex I to the MDR.
Use of harmonised standards
To demonstrate that a device meets the requirements, the manufacturer may choose to follow international standards developed in different areas. Harmonised standards have been developed to correspond to the requirements of the regulations.
Following the standards is voluntary, but they provide a useful way to demonstrate compliance with specific regulatory requirements.
Work is underway to harmonise standards with the MDR. For the time being, the latest standards harmonised under the previous directives and published on the European Commission’s website may be used.
- Harmonised standard General Medical Devices External link.
- Harmonised standard Active Implantable Medical Devices External link.
Quality management and risk management
Under the regulations, manufacturers must follow a quality-assured process with a focus on systematic risk management throughout the medical device’s entire lifecycle. Relevant harmonised standards include ISO 13485 and ISO 14971.
The applicable standards and required investigations vary depending on the device. They must be addressed to demonstrate compliance with the general safety and performance requirements, as far as possible without testing in humans.
Only then is the device ready for use in a clinical investigation involving human subjects.
Guidance on standards
For guidance on suitable standards, consult industry organisations such as Swedish Medtech and MEDEA.
The Swedish Life Sciences Database also provides a searchable overview of key organisations in the medical device sector, including consultancies and companies with expertise in medical devices.
- Swedish Medtech External link.
- MEDEA (in Swedish) External link.
- Swedish Life Sciences Database External link.
CE marking and regulatory compliance
CE marking of a medical device is a procedure that ensures that the device meets the requirements of all applicable EU regulations.
To obtain CE marking for a medical device, the manufacturer must first ensure that the general safety and performance requirements set by the regulations are met. For medical devices, these requirements are specified in Annex I to the MDR.
Depending on the device’s design and function, other EU directives may also apply, such as specific directives for machinery.
In such cases, the requirements of those directives must also be met before the device can be CE marked.
Steps in the CE marking process, Swedish Medical Products Agency's website External link.
In-house medical devices
Healthcare institutions may develop new medical devices or modify existing devices to meet specific healthcare needs without following the CE marking process or undergoing review by a notified body.
These are referred to as in-house devices and are further defined in Article 5(5) of the MDR.
In-house devices may only be used within the healthcare institution that produced them. In-house manufacturing may only take place if no equivalent device is already available on the market.
In-house devices must also meet the general safety and performance requirements set out in the MDR. A clinical investigation may sometimes be required to meet these requirements.
The healthcare institution is responsible for ensuring that in-house manufacturing of medical devices takes place within an appropriate quality management system.
If you conduct a study of an in-house device, be aware that manufacturing processes may vary between hospitals and healthcare institutions. Follow your organisation’s procedures for in-house manufacturing.
Article 5(5) of the EU Regulation on medical devices, EUR-lex website External link.
Stay up to date with the regulations
The information on this website is based on the legislation currently in force. The Swedish Medical Products Agency continuously updates its website with information about legislation, transitional provisions and frequently asked questions.
Subscribe to the Swedish Medical Products Agency’s newsletter to receive information about medical device regulations and changes to the regulatory framework.
Applicable legislation
The EU Medical Devices Regulation (MDR) came into effect on 26 May 2021. In areas where the MDR allows for national legislation, the following provisions also apply from 15 July 2021:
- Medical Devices Regulation (EU) 2017/745 (MDR) External link.
- Act with supplementary provisions to the EU Medical Devices Regulation (SFS 2021:600) External link.
- Act with supplementary provisions on ethical review to the EU Medical Devices Regulation (SFS 2021:603) External link.
- Swedish Medical Products Agency regulations (HSLF-FS 2021:32) with supplementary provisions to the EU Medical Devices Regulation. External link.
Medical devices for in vitro diagnostics (IVDR)
Find out whether your idea involves an in vitro diagnostic medical device
Performance studies of in vitro diagnostic medical devices are governed by the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which came into effect on 26 May 2022.
What is an in vitro diagnostic medical device?
In vitro diagnostic medical devices, also referred to as IVD devices, are intended to examine specimens from the human body. They can provide information about matters such as the effects of a particular treatment or the progression of a disease.
The EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into effect on 26 May 2022.
The IVDR contains the complete definition of an in vitro diagnostic medical device. It also sets out the rules for classifying IVD devices as Class A, B, C or D.
If you are unsure whether it is an IVD device
It can sometimes be difficult to determine whether a device you intend to use is an in vitro diagnostic medical device. Contact the Swedish Medical Products Agency (Läkemedelsverket) for advice if you are unsure.
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 External link.
Clinical performance studies
As a general rule, clinical performance studies should be conducted to confirm the clinical performance of a device, unless relying on other sources of clinical performance data can be justified.
After a clinical performance study has been conducted, the resulting data should be included in the performance evaluation. The data form part of the clinical evidence supporting the use of the device.
Performance evaluation of the device
A manufacturer planning to conduct a clinical performance study before CE marking a device must first perform a performance evaluation. Performance evaluation is a process in which data are assessed and analysed to demonstrate:
- scientific validity
- analytical performance
- clinical performance confirming the intended purpose of the device.
The methodology for performance evaluation is described in Article 56 and Part A of Annex XIII to the IVDR.
In brief, the methodology involves collecting clinical data from the scientific literature according to specified criteria and evaluating the data systematically. The findings are documented in a written report.
The report shows whether existing data demonstrate that the device meets the general safety and performance requirements or whether certain aspects need to be investigated in new clinical performance studies.
Formulate the hypothesis or research question
To maximise the value of an IVD device in healthcare, manufacturers should ensure that the characteristics being evaluated are supported by evidence-based research and aligned with the needs and interests of the intended users.
Claims about safety and performance must be supported by clinical data. During the development stage, it may therefore be valuable to consult:
- leading clinical researchers in the relevant field
- intended users
- relevant diagnostic groups
- representatives of the relevant professions.
The risk management process and the results of the performance evaluation help identify which aspects of the device require further assessment and which questions should be addressed in a clinical performance study.
For more information about study planning and statistical considerations, see the Planning and Analysis pages.
Notify or apply for authorisation for a clinical performance study
Under the IVDR, certain clinical performance studies require either a notification or an application to the Swedish Medical Products Agency.
Follow Good Study Practice (GSP)
The Swedish Medical Products Agency recommends that all clinical performance studies are conducted in accordance with the international standard ISO 20916:2024, In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice.
The purpose of ISO 20916:2024 is to:
- protect the rights, safety and well-being of study subjects
- ensure scientifically rigorous study conduct and reliable results
- define responsibilities
- support the parties involved in assessing whether an in vitro diagnostic medical device conforms to the general safety and performance requirements.
ISO standards, SIS' website (login required) External link.
General requirements and harmonised standards
General safety and performance requirements
The safety and performance requirements for in vitro diagnostic medical devices are referred to as the general safety and performance requirements. They are set out in Annex I to the IVDR.
A manufacturer must ensure that a device intended for a performance study meets the general safety and performance requirements, except for the aspects covered by the performance study.
EU regulation on medical devices for in vitro diagnostics External link.
Using harmonised standards
International standards developed for different areas can be used to demonstrate that a device meets the requirements. Harmonised standards have been developed to correspond to the requirements of the regulations.
Following standards is voluntary, but it is a useful way to demonstrate compliance with specific regulatory requirements.
Work is underway to harmonise standards with the IVDR. For the time being, standards harmonised under the previous directives and published on the European Commission’s website can be used. There are also EU-wide specifications that should be followed.
- Harmonised standards in vitro diagnostic medical devices External link.
- Common technical specifications, EU regulations External link.
Different standards apply depending on the device being studied. Various examinations or studies of the device may therefore need to be completed before the general safety and performance requirements can be considered fulfilled.
CE marking and regulatory compliance
CE marking of an in vitro diagnostic medical device is a procedure intended to ensure that a CE-marked device meets the requirements of all applicable EU regulations.
To CE mark an in vitro diagnostic medical device, the manufacturer must ensure that the general safety and performance requirements set out in the regulations are met. For in vitro diagnostic medical devices, these requirements are specified in Annex I to the IVDR.
Steps in the CE marking process, the Swedish Medical Products Agency's website External link.
In-house in vitro diagnostic medical devices
Healthcare institutions may develop new in vitro diagnostic medical devices or modify existing devices to meet specific healthcare needs without undergoing the CE marking process or review by a notified body. These are referred to as in-house devices and are further defined in Article 5(5) of the IVDR.
Article 5(5) of the In Vitro Diagnostic Medical Devices Regulation External link.
The requirements for custom manufacturing in the EU Regulation on medical devices for in vitro diagnostics will be introduced gradually. Read more about this on the Swedish Medical Products Agency's website.
In-house devices may only be used within the healthcare institution that produced them. In-house manufacturing may only take place if no equivalent device is already available on the market.
In-house devices must also meet the general safety and performance requirements set out in the IVDR. The healthcare institution is responsible for ensuring that in-house manufacturing takes place within an appropriate quality management system.
In-house in vitro diagnostic medical devices can be evaluated in performance studies in the same way as other medical devices.
If you conduct a study of an in-house device, be aware that manufacturing processes may vary between hospitals. Follow your organisation’s procedures for in-house manufacturing.
Medical device legislation is changing
Medical device legislation in Sweden and the EU is currently being updated. The information on this website is based on the legislation currently in force.
Stay up to date with the new legislation
The Swedish Medical Products Agency continuously updates its website with information about new legislation, relevant transitional provisions and frequently asked questions. Subscribe to the agency’s newsletter for updates about medical device regulations and changes to the regulatory framework.
Related information about Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) are biological medicinal products based on genes, cells or tissue engineering. ATMPs are regulated by common EU legislation supplemented by Swedish legislation.
The links below provide further information, regulatory guidance, templates and training.
- Advanced therapy medicinal products, Swedish Medical Products Agency website External link.
- Guides, templates and regulatory support, ATMP Sweden website External link.
- ATMP classification and regulatory information, European Medicines Agency website External link.
- Online course: Introduction to advanced therapies, Swedish Academy of Pharmaceutical Sciences website External link.
Research support for clinical trials involving advanced therapy medicinal products
Contact your regional node within Clinical Studies Sweden to find out what research support is available for your study.
Contact your regional node within Clinical Studies Sweden External link.
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