Legislation on post-market surveillance and vigilance

MDR/IVDR

The requirements on PMS and vigilance for all medical devices (including custom-made devices) and in vitro diagnostic medical devices (IVD devices) are described in chapter VII in the MDR and IVDR respectively.

The EU regulations are supplemented amended by national legislation on measures for PMS and vigilance to handle the absence of Eudamed.

Legislation based on MDD/AIMDD/IVDD

The requirements on PMS and vigilance in the directives MDD/AIMDD/IVDD are implemented are implemented by three national legal acts (Läkemedelsverkets föreskrifter). As for the regulations, the requirements apply to all medical devices (including custom-made devices) and in vitro diagnostic medical devices (IVD devices).

The wording of the requirements on PMS and vigilance is brief and at an insufficient level of detail in the legislation based on MDD/AIMDD/IVDD. Therefore, the guidance document MEDDEV 2.12/1 has become the de facto legislation on PMS and vigilance.

Nationella medicinska informationssystem (NMI)

The requirements on PMS and vigilance for NMI according to HSLF-FS 2022:42 are found in 6 kap. of the regulation.

The requirements on PMS and vigilance for NMI according to LVFS 2014:7 are formally the same as in the legislation based on MDD/AIMDD/IVDD. However, the Swedish Medical Products Agency (Läkemedelsverket) considers it as best practice to apply the NMI-specific requirements in HSLF-FS 2022:42.