Specific rules for medical devices
Find out whether your idea includes a medical device
Medical devices include a large number of different products intended for use to indicate, treat or relieve a disease or injury in humans, for example.You can read more about the definition of a medical device in the Swedish Medical Devices Act (SFS 1993:584, in Swedish), on the Swedish Medical Products Agency’s website, and on the page about medical devices.
The intended use is the manufacturer’s description of a product’s area of use and determines whether it shall be defined as a 1 medical device. If you have developed a device, or if you have modified an existing device, it may be that you or the organisation you belong to are the manufacturer, and then it is you yourselves who have to define the intended use and find out whether it is a medical device. You can read more about manufacturer’s liability and how to find out who is the legal manufacturer on the Swedish Medical Products Agency’s website.
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, in particular if the product is to be used in combination with a medicine, for example. If so, please contact a notified body or the Medical Products Agency for advice. The EU Commission also publishes guidelines dealing with delimitation problems.
Is the product ready to be used in a clinical study?
Before the medical device can be used in a clinical study, it shall fulfil the regulatory 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’ “significant requirements” below on this page.
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 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 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 study.
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 under Planning and Analysis.
Clinical evaluation of the product
A clinical evaluation is one of the activities the manufacturer must carry out to investigate whether the device fulfils the significant requirements for safety and performance.
A detailed method description of how to carry out clinical evaluation is available in the EU Commission’s guideline document MEDDEV 2.7/1. 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 requirements using existing data, or whether there are aspects that may need to be tested in new clinical studies.
Which studies need a permit from the Medical Products Agency?
Some clinical studies that involve medical devices shall be notified to and need a permit from the Medical Products Agency. It is important to find out early whether the study requires a permit, as this impacts on many aspects of the continued study planning, including how you formulate your hypothesis or research question. Read more about how to find out whether your study needs a permit from the Medical Products Agency under Planning.
The manufacturer’s documentation for the medical device is needed ahead of notification of a clinical study. If you are not the manufacturer of the product to be used, you should contact the manufacturer to draw up a collaboration that makes it possible to use the product in a clinical study.
Recommendation to follow good clinical practice
The Medical Products Agency recommends that all studies of medical devices that require a permit are conducted according to the European harmonised standard ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice. We recommend that you follow ISO 14155 during all stages of a study, from planning to conclusion and archiving. The purpose of ISO 14155 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 significant requirements
All Swedish healthcare personnel have access to standards, including ISO 14155 via internet by means of an agreement between Swedish Standards Institute (SIS) publishers and SKR.
Significant requirements and harmonised standards
The requirements set for safety and performance for medical devices are known as the “significant requirements” and are listed in Appendix 1 to the Medical Product Agency’s regulations for the various categories of device (in Swedish) (LVFS 2003:11, LVFS 2001:5 and LVFS 2001:7).
To show that the product fulfils the requirements, you can choose to follow the internationally harmonised 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 a specific significant requirements in the regulations has been managed in a suitable way. The EU Commission’s website has a list of harmonised standards that may be applicable to medical devices.
Depending on the product studied, different standards may be applicable, and different types of activities may be required before the product can be said to be ready for testing on human subjects. If you need help in the choice of standards to show that the significant requirements have been fulfilled, you can find references to relevant resources you can use via the industry organisation Swedish Medtech, or MEDEA (in Swedish), 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.