Specific rules for medical devices
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.
Registered with the Swedish Medical Products Agency
Clinical investigations of medical products must be registered or applied for to the Swedish Medical Products Agency. Information about this is available on the Swedish Medical Products Agency’s website and there is also has a summary of the regulations and guidance documents that apply for trials involving medical devices.
Authorization procedures for clinical investigations of medical devices
Regulations for clinical investigations of medical devices
New EU regulation
From 26 May 2021, EU Regulation 2017/745 on medical devices will be applied within the EU. Clinical investigations of medical devices that have received a permit before 26 May 2021 are conducted in accordance with the regulations that applied at the time of the permit. Exceptions apply to safety reporting that may be performed in accordance with the new regulations, EU regulation (2017/745) on medical devices.
About safety reporting according to the new regulations, EU regulation (2017/745) on medical devices
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.
