Medical devices include products and solutions that provide conditions for preventing, diagnosing, treating and alleviating most types of diseases.
What is a medical device?
According to the law, a medical device is a product (in Swedish) that shall be used on humans, separately or in combination with something else, to:
- indicate, prevent, monitor, treat or relieve a disease
- indicate, monitor, treat, relieve or compensate an injury or a functional disability
- investigate, change or replace parts of the anatomy or a physiological process
- control fertilisation
A product that achieves its intended effect primarily with the help of pharmacological, immunological or metabolical means is not a medical device. Further information about definitions of medical devices is available on the Swedish Medical Products Agency’s website.
Different types of devices
In the EU, medical devices are divided up into three different categories for regulatory purposes. The Medical Products Agency has produced instructions for each of the device categories, with regulations for the requirements set for product safety and performance , and for what applies during clinical evaluation and clinical studies of medical devices.
The three categories are:
Medical devices for in vitro diagnostics, which is covered by the Medical Product Agency’s instruction LVFS 2001:7 (in Swedish). The instruction includes the full definition of an in vitro diagnostic device, and a division of the devices into two subsidiary groups, List A and List B. The in vitro diagnostic devices that are not included on Lists A or B are called “general” in vitro diagnostic products.
Active medical devices for implantation, which are devices driven by an energy source and are intended to be left in the body following implantation. Active implants are always associated with high levels of risk, and are therefore not divided up into different risk classes. The medical devices are covered by the Medical Product Agency’s instruction LVFS 2001:5 (in Swedish).
General medical devices, which are covered by the Medical Product Agency’s instruction LVFS 2003:11 (in Swedish). General medical devices are divided up into different risk classes: Class I, IIa, IIb and III.
Changes to medical legislation
The legislation that has regulated the medical devices area in Sweden since 1993 is based on three European Directives, which have been implemented in Sweden via:
- the Medical Devices Act (SFS 1993:584)
- the Medical Devices Ordinance (SFS 1993:876) and via the Medical Products Agency’s three instructions on:
- general medical devices (LVFS 2003:11)
- active medical devices for implantation (LVFS 2001:5)
- medical devices for in vitro diagnostics (LVFS 2001:7)
New legislation in the form of two new EU regulations have been produced, which will gradually replace the current three directives. This means that the two directives on medical devices and active medical devices for implantation are merged into a new Medical Devices Regulation (MDR), and the directive on in vitro diagnostic products is replaced by a In Vitro Diagnostics Regulation (IVDR). The regulations were adopted by the European Parliament and the Council of the European Union in June 2016 and came into force on 26 May 2017. The two new regulations came into force at the same time, but they start applying at different times. They will apply in parallel with the previous legislation for a period of three (MDR) and five (IVDR) years respectively. The old legislation that was based on the directives will gradually be replaced by or be adapted to the regulations.
The Medical Products Agency publishes information continuously (in Swedish) on the new legislation, the transfer rules that apply, as well as FAQ. Further information is available on the EU Commission website.
Guarantee that the device complies with requirements for safety and performance
CE-marking of medical devices is a process that shall guarantee that products with CE-marking comply with the requirements of all possible regulations within the EU.
Further information on the various steps in the CE-marking process (in Swedish) and a guide is available on the Medical Products Agency’s website (in Swedish). This also has guidelines developed specifically for manufacturers of medical devices covered by Class I (in Swedish), in vitro diagnostic devices (in Swedish), and of medical information systems (in Swedish).
How are the significant requirements complied with?
To comply with the significant requirements, the manufacturer shall systematically check the characteristics of the device, for example by complying with various harmonised standards. For in vitro diagnostic products on List A, there are also common EU technical specifications that must be complied with.
The regulations also require that the manufacturer works in a quality-assured way and applies systematic risk management throughout the life of the device, for example by complying with the harmonised standards ISO 13485 and ISO 14971.
Own-production medical devices
Healthcare organisations have the opportunity to develop new or modify existing medical devices to satisfy specific needs in healthcare, without having to undergo a CE-marking process or scrutiny by “notified bodies” (in Swedish). These products are known as “own production” and are defined in the National Board of Health and Welfare’s instruction SOSFS 2008:1 (in Swedish). The framework for own production devices also covers medical devices that are used or combined in healthcare in a new way not intended by the original manufacturer.
Own production devices may only be used in the own operation, and does not cover devices that a patient can bring home with them. The requirements for safety and performance set for own production devices must not be lower than those set for a CE-marked product. The healthcare organisation is responsible for ensuring there are specific procedures for own production of medical devices that safeguard all product documentation is available. The operational manager at the unit where the device is used shall certify that the product fulfils all the significant requirements set in applicable instructions, and that would have been set for a corresponding CE-marked device.
Further information about own production (in Swedish) devices is available on the Medical Products Agency’s website. The use of own production devices is regulated by the National Board of Health and Welfare (in Swedish), and the Health and Social Care Inspectorate (in Swedish) is responsible for supervision.
Different rules for different types of medical device studies
Many clinical studies involve medical devices in one way or another. However, all studies are not covered by the specific rules for medical devices that apply for studies that need to be notified to the Medical Products Agency. Read more about which studies that need to be notified in the Idea and Planning tabs in Clinical studies – step by step.
Clinical studies involving own production devices and CE-marked devices used in the way intended by the manufacturer do not need to be notified. However, these studies do have to comply with the rules that apply for all clinical research, such as ethical review, handling of sensitive personal data and rules governing collection of biobank samples.
A person conducting studies of own production devices should be aware that the procedure involving own production may differ from hospital to hospital. If own production is present at several care providers, the procedures for own production according to SOSFS 2008:1 (in Swedish) in each organisation shall be complied with.
If an adverse event or incident occurs in a medical device study not requiring a permit, then this shall be reported to the manufacturer and the Medical Products Agency for CE-marked devices, and to the Health and Social Care Inspectorate for own production devices (in Swedish).