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Specific rules for medical devices

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.

Coordinated review from the Swedish Medical Products Agency and the Swedish Ethical Review Authority

From 15 July 2021, most of clinical investigations of medical devices must be submitted to the Swedish Medical Products Agency. The Swedish Medical Products Agency and the Swedish Ethical Review Authority coordinate their review and thus the application for ethical review must be sent to the Swedish Medical Products Agency. Also note that clinical investigations of medical devices on CE-marked products that previously only needed to be sent to the Swedish Ethical Review Authority must be notified to the Swedish Medical Products Agency from 15 July 2021. Information about the notification procedure is available on the websites of the Swedish Medical Products Agency and the Swedish Ethical Review Authority

Notification and application for clinical investigations of medical devices, the Swedish Medical Products Agency External link.

Notification and application for clinical investigations of medical devices, the Swedish Ethical Review Agency External link.

Medical devices - current EU regulation and national legislation

From 26 May 2021, EU Regulation 2017/745 on medical devices are applied within the EU. As of 15 July 2021, two new Swedish laws also apply:

Clinical investigations of medical devices must comply with the rules for notification and permit requirements that applied at the time when the trial received the applicable permits.

Clinical investigations of medical devices that did not need to be sent to the Swedish Medical Products Agency before 26 May 2021 and that received permission from the Swedish Ethical Review Authority before 26 May 2021 do not need to be reported to the Swedish Medical Products Agency afterwards.

More information about the regulations in their entirety regarding medical devices can be found on the page Medical Devices on this website

Regulations for clinical investigations of medical devices, The Swedish Medical Products Agency's website External link.

Medical devices for in vitro diagnostics - new EU regulation

New rules apply within the EU from 26 May 2022 when the EU Regulation 2017/746 on medical devices for in vitro diagnostics (IVDR) will be applied.

IVDR defines a performance study as a study conducted to determine or confirm the analytical or clinical performance of a product.

The purpose of clinical performance studies is to establish or confirm aspects of product performance that cannot be determined through analytical performance studies, literature studies, and / or previous experience from routine diagnostic testing.

Performance studies that are started before IVDR has started to be applied may continue to be carried out in accordance with the previous regulations (LVFS 2001: 7 based on IVDD) f even after the application date for IVDR. Sponsor does not need to submit any application or application to the Swedish Medical Products Agency for ongoing performance studies.

EU regulation on in vitro diagnostic medical devices, EUR lex website External link.

Information about regulations, IVDR, the Swedish Medical Products Agency's website External link.