Ordförklaringar:

Idea

  • The design and method of the study are important

    A research plan is necessary for ethical review applications, and functions as a handbook

    Statistical analysis plan

    Information to study participants before consent

    Find out what insurance cover is available for the study participants

    Study budget for all the costs in the project

    Is a health economics evaluation of the study needed?

    Checklist to help plan studies on human

    To consider

  • Applying for an ethical review

    Research projects in which study participants are irradiated

    Application for access to biobank samples

    Finding out what applies for handling of personal data

    Register your study before the start of the study

  • Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Please consider

  • Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Specific rules for medical devices

    Links and related information

  • Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • Public documents must be archived

    Screening of personal data

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map out the research status.

An idea can result from systematic research, but it can also arise spontaneously as a possible solution to an everyday problem. Within health and medical care, it is often a question of creative solutions to work methodology problems, or of new products that will contribute to the development of healthcare work. It is not uncommon either for research to be carried out into methods or interventions that are already in use, but lack scientific evidence for their effect, or to investigate whether therapies developed for a specific indication can also be used in other contexts.

Health and medical care or clinical research?

Health and medical care refer to measures aimed at preventing, investigating and treating diseases and injuries medically. Health and medical care shall be conducted according to science and tried-and-tested experience. The rules for how health and medical care shall be exercised are included in legislation, such as the Health and Medical Services Act (SFS 2017:30), the Patient Safety Act (SFS 2010:659) and the Patient Act (SFS 2014:821). For research, other rules apply, and the requirement for science and tried-and-tested experience do not apply to therapies tested within the framework for a clinical study. On this website, you can find information about what applies when you carry out a clinical study.

Compare your idea with previous research

By carrying out a literature search and review of scientific publications, registers and databases, you can compare your idea for a new method, therapy or product with previous research carried out, and possibly find similar products on the market. Perhaps there is clinical data from previous research that support your idea, or information on development of similar products?

There are a number of databases you can search to find information about clinical studies in progress or completed. Some of them are:

Search for knowledge among systematic analyses

HTA, Health Technology Assessment, entails a systematic assessment of the knowledge status for a medical method, technology or therapy. The assessment is made from financial, as well as organisational and ethical perspectives, and is based on a review of the published scientific literature, according to SBU’s principles for study quality. New technology is often compared to existing technology. The purpose of the HTA analysis is to make healthcare more evidence-based.

The assessments are carried out at national level by SBU and the Dental and Pharmaceutical Benefits Agency (TLV) , and at regional level by HTA organisations in the regions.

About the assessments and information about the HTA organisations External link. (in Swedish) External link., SBU website External link.

About the assessments, Dental and Pharmaceutical Benefits Agency (TLV) External link.

Search for gaps in scientific knowledge

If you want help with understanding where the need for clinical research is the greatest, you can get tips about a large number of insufficiently evaluated methods and interventions in health and medical care and social services, or “gaps in scientific knowledge”. SBU has mapped areas where there is a need for more knowledge, based on SBU’s own reports, the national guidelines of the National Board for Health and Welfare and other systematic literature summaries. The identified gaps in knowledge are published on SBU’s website, where you can search among lots of suggestions for research within a vast number of areas.

Identified gaps in knowledge, SBU's website External link.

Use data found in registers

Public authorities have a large number of registers that have been collected within the framework for each authority’s activities. Several authorities have data from population-based surveys and questionnaires, which have been gathered together primarily for purposes other than research. Of particular interest to clinical studies are health data registers, for example.

Health and medical care in Sweden maintains a quality register, which has been built up within specific areas in order to develop and safeguard care quality systematically and continuously. Register studies can also be used to follow up and evaluate benefits and risks of various medicines and other forms of therapy.

At registerforskning.se, there is information aimed at researchers who want to use register data in their research. It provides support for the work of identifying, ordering and using register data.

Formulate the problem

The formulation of the problem is the core of every research process, and the clearer the problem and the primary question of the project is formulated, the clearer and more concrete the purpose of the project in question becomes. Once you have formulated a concrete research question, you can also determine the data that need to be collected in order to answer the question.

Your formulation of the research question forms the basis for the research plan that is needed for the application to the Swedish Ethical Review Authority.

Good things to consider

  • Is the idea unique?
  • What questions do you want to answer?
  • What material do you need to collect to answer the question?
  • What is the patient or societal benefit?
  • How shall the information be analysed?

Specific rules for medicinal products or medical devices

There are specific rules to attend to if your idea includes a medical device.

Please note: from 31 January 2022, a new EU-wide regulation on clinical trials on medicinal products applies. More information is available on the Swedish Medical Products Agency’s website. External link.

Find out if your idea or question involves medicinal products

If your study includes medicinal products, i.e. a clinical trial on a medicinal product, you need to find out if it is a clinical trial on medicinal products that requires a permit or not. In Sweden, a clinical trial on medicinal products must be granted a permit after examination by both the Swedish Medical Products Agency and the Swedish Ethical Review Authority before it can start up. If the study is a non-interventional study, however, the study does not need to be reviewed by or obtain a permit from the Swedish Medical Products Agency.

Find out if your study is subject to a permit or not, the Swedish Medical Products Agency's website External link.

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.

Find out whether your idea includes a medical device

If you are planning for a medical technical clinical trial on as part of the product development prior to CE marking, you probably already know whether the product in your study is defined as a medical technology product or not. However, this is not always as obvious in studies initiated by academia or by healthcare.

Medical devices encompass various types of instruments, apparatus, software, or other articles intended for medical purposes, such as detecting, treating, or alleviating a disease or injury in humans. Some products without medical purposes are also included in the definition and listed in Annex XVI of the EU Regulation on medical devices.

A product that achieves its intended effect primarily through pharmacological, immunological, or metabolic means is not considered a medical device.

You can read the complete definition of a medical device in the EU Regulation on medical devices, and there is more information available on the website of the Swedish Medical Products Agency.

The so-called intended purpose is the manufacturer’s description of a product’s area of use and determines whether it shall be defined as amedical device. If you intend to study a product that you have designed yourself, if you want to use a product for medical purposes that was not originally intended for it, or if you have modified an existing medical device, it may be that you or the organisation you belong to are the manufacturer. In these cases it is you yourselves who are responsible for finding out whether the medical product fulfills the definition for a medical device and thus must also follow the special rules that apply to clinical trials on medical devices.

If you are proposing to use a commercially available product in your study, you can find out whether it is defined as a medical device by contacting the manufacturer.

Sometimes it is difficult to assess whether the product you are proposing to use is a medical device or not. If so, please contact the Swedish Medical Products Agency for advice. The EU Commission also publishes guidelines dealing with delimitation problems around, for example, medical technology software.

The definition of a medical device in the EU regulation, EUR-Lex website External link.

Information about definitions, the Swedish Medical Product Agency's website External link.

Guidance on medical technology software: MDCG 2019-11, The European Commission's website External link.

Different Types of Products

Medical devices in the EU are regulated and categorized into two categories, following different regulatory frameworks:

Medical devices covered by the EU Regulation on medical devices. This product category is divided into various risk classes: Class I, IIa, IIb, and III. The classification of risk is determined, among other factors, by the product's degree of invasiveness and whether it is an "active" product that adds or exchanges energy with the human body.

In vitro diagnostic medical devices covered by the EU Regulation on in vitro diagnostic medical devices. Refer to the information under the "In vitro diagnostic medical devices" section below.

Is the product ready for use in a clinical investigation of medical devices?

Before the medical device can be used in a clinical investigation of medical devices , it shall fulfil the regulatory, so-called general, requirements for safety and performance, as far as is possible without testing it on humans. For example, technical and biological safety tests shall have been conducted and all risks shall have been minimised and balanced against expected clinical benefit. Read more about the regulations’ general requirements below on this page.

Clinical evaluation of the product

A manufacturer planning to perform clinical investigation of medical devices prior to CE marking of their product must first perform a clinical evaluation.

A method description of how to carry out clinical evaluation is available in the EU regulation on medical devices, appendix XIV. In brief, the method consists of collecting data from literature according to specific criteria, and then evaluating them in a systematic way. The evaluation is summarised in a written report, stating whether the device can be shown to fulfil all the general requirements on safety and performance using existing data, or whether there are aspects that may need to be tested in new medical technical clinical studies.

Method description for how clinical evaluation should take place, EU regulation on medical devices, Appendix XIV External link.

Formulate the hypothesis or research question

For the medical device to be used to its best potential in health and medical care, the manufacturer should ensure that the characteristics intended to build up evidence for are also those that the end user is interested in. Claims about the safety and performance of a device must be proved using clinical data, and it can therefore be valuable to discuss questions with key opinion leaders, proposed users, diagnosis groups or representatives of the clinical profession.

The risk management process used during the development of a medical device, together with the results from the clinical evaluation, provide information on the aspects of the products that should be evaluated, and thereby which questions should be answered in a possible clinical investigation of medical devices.

The development stage of the product is also of importance to how the hypothesis should be formulated, and whether the study should have an exploratory or confirmatory design, or perhaps both. You can read more about study design and statistical considerations on the pages Planning and Analysis on this website.

Guidance - Clinical Evidence for Medical Software: MDCG 2020-1: European Commission website External link.

Information about study design on the webpage Planning

Information about statistical considerations on the webpage Analysis

Most clinical investigations of medical devices require permission from the Swedish Medical Products Agency

Most clinical investigations of medical devices shall be notified to the Swedish Medical Products Agency and some also needs a permit from the same authority. Read more about notifications and permits from the Swedish Medical Products Agency on the page Planning or on the Swedish Medical Product Agency´s website.

Plan your study, information on registration or permit required

Notification and permission,The Medical Products Agency's website External link.

Recommendation to follow good clinical practice

The Swedish Medical Products Agency recommends that all medical technical clinical trials are conducted according to the European standard ISO 14155:2020, Clinical investigation of medical devices for human subjects – Good clinical practice. The purpose of ISO 14155:2020 is to:

  • protect the rights, safety and well-being of study participants
  • safeguard scientific implementation and reliable study results
  • define responsibilities
  • function as an aid for the parties involved in the assessment whether medical devices correspond to the general requirements on safety and performance

All Swedish healthcare personnel have access to many standards, including ISO 14155:2020 via internet by means of an agreement between Swedish Standards Institute (SIS) publishers and SKR.

Standards on SIS website (login required) External link.

General requirements and harmonised standards

The requirements set for safety and performance for medical devices are known as the “general requirements” and are listed in Appendix I to EU regulation on medical devices.

Medical devices, requirements and safety - Annex I, EU Regulation External link.

To show that the product fulfils the requirements, you can choose to follow the internationally standards that have been developed in various areas. Harmonised standards have been developed to comply with the requirements in the regulations. Working according to standards is voluntary, but they can be a good help to show that conformity with a specific requirement in the regulation. Work is underway to harmonize standards with the EU regulation on medical devices. For the time being, you can use the standards that have been harmonized with the previous directives and that have been published on the EU Commission’s website:

Harmonised standard General Medical Devices External link.

Harmonised standard Active Implantable Medical Devices External link.

The regulations also require manufacturers to work in a quality-assured manner and apply systematic risk management throughout the entire lifecycle of the product. This includes adhering to the harmonized standards ISO 13485 and ISO 14971, for instance.

Depending on the product studied, different standards may be applicable, and different investigations of the product may need to be done before the general requirements on safety and performance can be said to be met as far as possible without testing the product on humans. Only then is it ready for use in a medical technical clinical trial.

If you need help in the choice of suitable standards to use, you can find references to relevant resources you can use via the industry organisation Swedish Medtech, or MEDEA, for example. Swedish Life Sciences Database has compiled a searchable summary of the various actors within the medical devices area covering both medical device consultants, and also other companies with a medical device profile.

Swedish Medtech External link.

MEDEA (in Swedish) External link.

Swedish Life Sciences Database External link.

The product must comply with regulatory requirements

CE marking of medical devices is a procedure that ensures that products bearing the CE mark meet the requirements of all applicable regulations within the EU.

The different steps in the CE marking process, Swedish Medical Products Agency's website External link.

To obtain CE marking for a medical device, the manufacturer must ensure that the general requirements for safety and performance set by the regulations are met. For medical devices, these requirements are specified in the EU Regulation on medical devices, Annex I.

Depending on the design and function of the medical device, other EU directives may also be applicable, such as the Machinery Directive for large equipment. In such cases, the requirements of these directives must also be fulfilled for the product to be CE marked.

Custom-made medical devices

Healthcare institutions have the opportunity to develop new or modify existing medical devices to meet specific healthcare needs without undergoing the CE marking process or review by notified bodies. These products are called custom-made and are defined in Article 5.5 of the EU Regulation on medical devices.

Article 5.5 of the EU Regulation on medical devices, EUR-lex webpage External link.

Custom-made products can only be used within the healthcare institution that produced them, and custom manufacturing can only be carried out if there is no equivalent product already on the market. The general requirements for safety and performance specified in the EU Regulation on medical devices must also be met for custom-made products. The healthcare institution is responsible for ensuring that custom manufacturing of medical devices is conducted within the framework of appropriate quality management systems.

Custom-made medical devices can, like other products, be evaluated in clinical investigations. Those conducting studies on custom-made products should be aware that the custom manufacturing process may vary across different hospitals. The respective organization's procedures for custom manufacturing should be followed.

Medical device legislation in transition

The medical device legislation in Sweden and the EU is undergoing changes, and the information on this website is based on the current applicable legislation.

Applicable legislation

As of May 26, 2021, the EU Medical Device Regulation (MDR) is in effect. To regulate areas where the EU Medical Device Regulation allows for national legislation, the following also apply as of July 15, 2021:

Stay updated on the new legislation

The Swedish Medical Products Agency provides continuous information about the new legislation, applicable transitional rules, and frequently asked questions. Subscribe to their newsletter on medical devices and the new regulatory framework.

Information about legislation, European Commission's website External link.

Newsletter on medical devices and new regulations, Swedish Medical Products Agency's website. External link.

Medical devices are in the EU regulated by two categories that follow different regulations. 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.

If your idea includes in vitro diagnostic products

In vitro diagnostic (IVD) products include products that are intended to be used for the examination of samples from the human body in order to obtain information about, for example, treatment effects or disease states.

You can read the complete definition of an in vitro diagnostic product in the EU regulation on in vitro diagnostic medical devices.

Sometimes it is difficult to assess whether the product you intend to use is a medical device for in vitro diagnostics or not. In that case, contact the Swedish Medical Products Agency for advice.

EU regulation on in vitro diagnostic medical devices External link.

Clinical performance studies

As a general rule, clinical performance studies should always be performed to prove the clinical performance of a product, unless it is justified to rely on other sources of clinical performance data.

When conducting clinical performance studies, the data obtained should be used in the performance evaluation and form part of the clinical evidence for the product.

Performance evaluation

A manufacturer planning to perform clinical performance studies prior to CE marking of its product must first perform a performance evaluation. The performance evaluation of a product is a process where data is assessed and analyzed to prove the scientific validity, the analytical performance and the clinical performance for the intended purpose of the product.

A methodological description of how to conduct clinical evaluation can be found in the EU Regulation on in vitro diagnostic medical devices, Article 56 and Part A of Annex XIII. In short, the method is based on clinical data from the literature being collected according to specified criteria and evaluated in a systematic way. The evaluation is summarized in a written report stating whether the product can be shown to meet the general requirements for safety and performance (see more about the general requirements further down the page) using existing data or if there are aspects that need to be tested through new clinical performance studies.

Formulate a hypothesis or research question

In order for the in vitro diagnostic product to be of the best use in healthcare, the manufacturer should ensure that the properties on which it intends to build evidence are also those that the final recipient is interested in. Claims about the safety and performance of a product must be demonstrated through clinical data, and it may therefore be valuable to discuss issues with leading clinical researchers in the field, potential users, diagnostic groups or representatives of the clinical profession.

The risk management process applied during the development of an in vitro diagnostic product together with the results of the performance evaluation provides information on which aspects of the product should be evaluated and thus which questions should be answered in a clinical performance study.

Read more about study design and statistical considerations under the pages planning and analysis.

Information about study arrangements

Information on statistical considerations

Some performance studies require review by the Swedish Medical Products Agency

With the application of the EU regulation on medical devices for in vitro diagnostics, notification or application for a permit from the Swedish Medical Products Agency is required for certain clinical performance studies on IVD products.

Information about application and registration, the Swedish Medical Products Agency's website External link.

Recommendation to follow good study practice

Clinical performance studies should be conducted in accordance with Good study practice (GSP), as described in the international standard ISO 20916: 2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice.

The purpose of ISO 20196: 2019 is to:

  • protect the rights, safety, dignity and well-being of the subjects
  • ensure scientific implementation and reliable study results
  • define responsibilities
  • serve as an aid to the parties involved in the assessment that in vitro diagnostic products comply with the general safety and performance requirements.

Standards on SIS website (login required) External link.

General requirements and harmonized standards

The safety and performance requirements for in vitro diagnostic products are called the general requirements and are listed in Annex I to the EU Regulation on in vitro diagnostic medical devices.

EU regulation on medical devices for in vitro diagnostics External link.

The manufacturer shall ensure that a product intended for performance studies meets the general safety and performance requirements, except for the aspects covered by the performance study.

To show that the product meets the requirements, you can choose to follow international standards that have been developed in different areas. Harmonized standards have been developed to meet the requirements of the regulations. It is voluntary to work according to standards, but they can be a good help to show compliance with a specific requirement in the regulations. Work is underway to harmonize standards with the EU regulation. For the time being, you can use the standards harmonized with the previous directives and published on the European Commission's website.

Harmonised standard in vitro diagnostic product External link.

There are also EU-wide specifications that should be followed.

Common EU technical specifications, EU regulations External link.

Depending on the product being studied, different standards will be applicable and different studies of the product will need to be done before the general requirements for safety and performance can be said to be met.

The product must comply with the regulatory requirements for safety and performance

CE marking of in vitro diagnostic products is a procedure that ensures that products bearing the CE mark meet the requirements of all applicable regulations within the EU.

The different steps in the CE marking process, the Swedish Medical Products Agency's website External link.

To obtain CE marking for an in vitro diagnostic product, the manufacturer must ensure that the general requirements for safety and performance set by the regulations are met. For in vitro diagnostic products, these requirements are specified in the EU Regulation on medical devices for in vitro diagnostics, Annex I.

Custom-made medical devices

Healthcare institutions have the opportunity to develop new or modify existing in vitro diagnostic products to meet specific healthcare needs without undergoing the CE marking process or review by notified bodies.

These products are called custom-made and are defined in Article 5.5 of the EU Regulation on medical devices for in vitro diagnostics.

Article 5.5 of the EU Regulation on medical devices for in vitro diagnostics 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.

Custom manufacturing, the Swedish Medical Products Agency's website External link.

Custom-made products can only be used within the healthcare institution that produced them, and custom manufacturing should only be performed if there is no equivalent product already on the market. This will also become a legal requirement as of May 26, 2028. The general requirements for safety and performance specified in the EU Regulation on medical devices for in vitro diagnostics must also be met for custom-made products. The healthcare institution is responsible for ensuring that custom manufacturing of in vitro diagnostic products is conducted within the framework of appropriate quality management systems.

Custom-made in vitro diagnostic products can, like other products, be evaluated in performance studies. Those conducting studies on custom-made products should be aware that the custom manufacturing process may vary across different hospitals. The respective organization's procedures for custom manufacturing should be followed.

Medical device legislation in transition

The medical device legislation in Sweden and the EU is undergoing changes, and the information on this website is based on the current applicable legislation.

Stay updated on the new legislation

The Swedish Medical Products Agency provides continuous information about the new legislation, applicable transitional rules, and frequently asked questions. Subscribe to their newsletter on medical devices and the new regulatory framework.

Newsletter on medical devices, the Swedish Medical Products Agency's website External link.

Additional information on legeslation, the European Commission's website External link.

Links and related information

The definition of a medical device in the EU regulation External link.

Information about definitions, the Swedish Medical Product Agengy´s website External link.

Guidance on medical technology software: MDCG 2019-11, The European Commission's website External link.

Method description for how clinical evaluation should take place, EU regulation on medical devices, Appendix XIV External link.

The European Commission's website, guidance on medical technology software: MDCG 2019-11 External link.

Information about study design on the page Planning

Information about statistical considerations on the page Analysis

Guidance - Clinical Evidence for Medical Software: MDCG 2020-1: European Commission website External link.

Plan your study, information on registration or permit required

Notification and permission,The Medical Products Agency's website External link.

Standards on SIS website (login required) External link.

Medical devices, requirements and safety - Annex I, EU Regulation External link.

Harmonised standard General Medical Devices External link.

Harmonised standard Active Implantable Medical Devices External link.

Swedish Medtech External link.

MEDEA (in Swedish) External link.

Swedish Life Sciences Database External link.

EU regulation on in vitro diagnostic medical devices External link.

Information about application and registration, the Swedish Medical Products Agency's website External link.

Harmonised standard in vitro diagnostic product External link.

Common EU technical specifications, EU regulations External link.

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