National Medical Information Systems – NMI – are information systems that are not medical devices in themselves, and therefore regulated by the provision HSLF-FS 2022:42. The provision is a standalone regulation, however very similar to MDR Annex I.
Since 2014, software systems in Sweden that are used on a national and regional level for handling data related to patient treatment, diagnostics, or prescriptions that are not medical devices are defined as National Medical Information systems (NMI). These systems are regulated under provisions provided by the Swedish Medical Products Agency (Läkemedelsverket, LMV). The most well-known examples are software systems used for sharing and distributing prescriptions and other pharmaceutical information as well as parts of the 1177.se services.
In the original NMI provisions from 2014 (LVFS 2014:7) the definition was fairly short. Manufacturers of such systems were imposed to follow applicable medical device requirements and register the system at the Swedish Medical Products Agency. The required handling of NMIs was very similar to class I MDD software, apart from some elements that were not applicable since these products are not classified as medical devices. Most importantly, this means that an NMI shall not be CE marked and that the clinical evaluation requirements don’t apply since the system by definition has no medical purpose.
However, in 2022 a new provision, HSLF-FS 2022:42, replaced the old text and included a more extensive definition, and the previous referral to the medical device regulations was removed. Instead, the provision is a standalone regulation very similar to the MDR Annex I General Safety and Performance Requirements with the same exceptions as earlier, but with the notable addition of a system for marking replacing the UDI requirement in the MDR. Software NMIs now need to be marked with an NMI-ID, an exclusive identification system defined in an annex of the provision.
Furthermore, the new definition includes a slightly wider range of products, including shared systems on a municipal level, placing more importance on the concept of joint and uniform use. Therefore, the number of systems registered as NMIs are expected to increase.
The transition period to release NMIs according to the requirements in LVFS 2014:7, or to put them into use, has expired. NMI released and put into service after 1st February 2023 must comply with the provisions of HSLF-FS 2022:42.
At QAdvis we see an increased number of questions regarding NMIs. If you need help with the regulatory aspects of your NMI, don’t hesitate to contact us. We can support you with the product qualification, technical documentation, quality management systems, and software specific tasks such as cybersecurity.
For more information we also recommend visiting the Swedish Medical Products Agency’s section on NMIs (in Swedish).
If you have any question, contact us at info@qadvis.com.
