Medical devices include products and solutions that provide conditions for preventing, diagnosing, treating and alleviating many types of diseases.
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.
- 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.
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 EU regulation on in-vitro diagnostic medical devices. 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 regulation contains the complete definition of an in vitro diagnostic product as well as classification rules which classify products into class A, B, C or D.
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 EU-regulation on in vitro diagnostic medical devices, Annex I. Depending on the design and function of the medical device, other EU -regulations may also be relevant, such as the Machinery Directive for large equipment. In that case, the requirements of these regulations 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, there are also EU-wide specifications that should be followed.
The regulations also require the manufacturer to work in a quality-assured manner and apply systematic risk management throughout the product's lifetime, for example by complying with the harmonized standards ISO 13485 and ISO 14971.
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, act 5.5 and in the EU regulation on in vitro diagnostic medical devices, Article 5 (5).
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 regulations. 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 or clinical performance studies. 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). External link. To regulate the areas where the EU regulation on medical devices leaves room for national legislation, from 15 July 2021 also applies:
- Law with supplementary provisions to the EU regulation on medical devices (SFS 2021: 600) (in Swedish) External link.
- Act with supplementary provisions on ethical review of the EU regulation on medical devices (SFS 2021: 603) (in Swedish) External link.
- The Swedish Medical Products Agency's regulations (HSLF-FS 2021: 32) on supplementary provisions to the EU regulation on medical devices (in Swedish) External link.
From 26 May 2022, the new regulation on in vitro diagnostic medical devices (IVDR) External link. and national legislation linked to it will apply.
Stay up to date
You can subscribe to the Swedish Medical Product Agency’s newsletters on medical devices and the new regulations External link. for updates.
Further information is available on the EU Commission’s website External link.