Specific rules for medical devices
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 include a large number of different products which in summary can be described as different technical solutions intended for use on humans for a medical purpose. You can read about the complete definition of a medical device in the EU regulation on medical devices, on the Swedish Medical Products Agencys´s website there is also information about definitions.
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.
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.
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.
All clinical investigation of medical devices require permission from the Swedish Medical Products Agency
All clinical investigation 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.
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 standards, including ISO 14155:2020 via internet by means of an agreement between Swedish Standards Institute (SIS) publishers and SKR.
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.
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.
When it comes to medical devices for in-vitro diagnostic there is still standards who are harmonised with the current EU directive:
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.