Medical devices include products and solutions that provide conditions for preventing, diagnosing, treating and alleviating many types of diseases.
New rules apply from 26 May 2021 - but some are delayed (preliminary) until 15 July 2021. Updates regarding the rules from 15 July will be published early autumn.
What is a medical device?
Medical devices include many different types of instruments, equipment, software or other articles intended for medical purposes such as to detect, treat or alleviate a disease or injury in humans. Some products without medical purposes are also covered by the definition and are listed in Annex XVI of the EU Regulation on medical devices.
A product that achieves its intended effect primarily with the help of pharmacological, immunological or metabolical means is not a medical device.
The complete definition of a medical device can be read in the EU regulation on medical devices and there is also more information on the Swedish Medical Products Agency's website.
Different types of devices
In the EU, medical devices are divided up in two categories which follow different regulations.
Medical devices, which are covered by the EU regulation on medical devices. This product category is divided up into different risk classes: Class I, IIa, IIb and III. The risk classification is determined, among other things, by the product's degree of invasiveness and whether it is a so-called “active” product that adds or exchanges energy with the human body.
Medical devices for in-vitro diagnostics, which is covered by Act (1993: 584) on medical devices and the Swedish Medical Product Agency’s instruction LVFS 2001:7. Medical devices for in-vitro diagnostics 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. 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 “common” or “general” in-vitro diagnostic products.
The device shall comply with regulation 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.
In order to be allowed to CE mark a medical device, the manufacturer must ensure that the regulations' so-called general requirements for safety and performance are met. For medical devices, the requirements are found in the EU regulation on medical devices, Appendix I. For medical devices for in-vitro diagnostics, the requirements are listed in the Swedish Medical Products Agency's regulation LVFS 2001:7. Depending on the design and function of the medical device, other EU directives may also be relevant, such as the Machinery Directive for large equipment. In that case, the requirements of these directives also need to be met in order for the product to be CE marked.
How are the general requirements complied with?
To comply with the general requirements, the manufacturer shall systematically check the characteristics of the device, for example by complying with harmonised standards. For in vitro diagnostic products on List A, there are also common EU technical specifications that must be complied with.
Own-production medical devices
Healthcare institutions 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”. These products are known as “own production” and are defined in the EU regulation on medical devices. 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 within the own health care institution and own production may only be carried out if there is no similar product on the market already.. The general requirements for safety and performance set in the EU regulation on medical devices for own production devices. The healthcare institution is responsible for own production of medical devicestakes place within the framework of appropriate quality management systems.
Self-manufactured medical devices can, just like other products, be evaluated in clinical investigations of medical devices. Anyone who conducts studies on self-manufactured products should be aware that the process of self-manufacturing can look different in different hospitals. The respective organisation's routines for own production must be followed.
Medical devices regulation in change
Medical devices regulation in Sweden and the EU is undergoing changes. The information on this website is produced based on the regulation that currently applies.
As from 26 May 2021* applies the EU Regulation on Medical Devices (MDR).
In-vitro diagnostic medical devices applies to Swedish legislation which is based on a European directive that has been implemented in Sweden through:
- the Medical Devices Act (SFS 1993:584)
- the Medical Devices Ordinance (SFS 1993:876)
and via the Swedish Medical Products Agency’s directive on:
- medical devices for in-vitro diagnostics (LVFS 2001:7)
In order to regulate the areas where the EU regulation on medical devices leaves room for national legislation, national legislation is also proposed to enter into force on 15 July 2021. The Swedish Medical Products Agency has also produced regulations linked to the national law, which are also proposed to enter into force on 15th July 2021.
From 26 May 2022, the new regulation on in vitro diagnostic medical devices (IVDR) and national legislation linked to it will apply.
Keep updated about the new regulation
You can subscribe to the Swedish Medical Product Agency’s newsletters on medical devices and the new regulations for updates.
Further information is available on the EU Commission’s website