Specific rules for medical devices
New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
Coordinated review from the Swedish Medical Products Agency and the Swedish Ethical Review Authority
From 15 July 2021, all 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
New EU regulation and national law
From 26 May 2021, EU Regulation 2017/745 on medical devices will be applied within the EU. As of 15 July 2021, two new Swedish laws also apply:
- Law with supplementary provisions to the EU regulation on medical devices (SFS 2021: 600) (in Swedish)
External link. - Law with supplementary provisions on ethical review of the EU regulation on medical devices (SFS 2021: 603) (in Swedish) External link.
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.
Note that for medical devices for in vitro diagnostics, the Act (1993: 584) on medical devices and the Swedish Medical Products Agency's regulation LVFS 2001: 7still apply until 26 May 2022, when new legislation also enters into force for this product category. Studies on medical devices for in vitro diagnostics do not require any notification to the Swedish Medical Products Agency in accordance with current legislation.
