Strengthen Your NMI Work with Expert Support
National Medical Information Systems (NMI) play a crucial role in Swedish healthcare by managing medical information that is important for individual patient treatment.
Since the new regulation HSLF-FS 2022:42 came into effect on August 1, 2022, the requirements for security, traceability, and documentation for NMI have been significantly tightened [1].
What is an NMI product?
An NMI product, or NMI (New Medical Information Systems), refers to software designed to manage, analyze, or visualize medical data without directly affecting patient treatment in the same manner as conventional medical devices. The primary distinction from standard medical devices is that NMIs are oriented toward information management and decision support rather than physical impact, diagnosis, or direct treatment. While medical devices are regulated under the MDR or IVDR, NMIs are subject to separate regulations with specific requirements for documentation, labeling, and traceability.
The NMI (Non-Medical Information) regulation referenced here applies to Sweden; however, there may be similar regulations in other countries, each with their own requirements and regulatory authorities. Organizations operating internationally should review relevant rules in every country where their products are marketed or used. Our consultants are available to provide guidance on Swedish requirements and considerations for compliance in other jurisdictions.
Compliance requirements
Unlike medical devices, NMI is not directly covered by MDR or IVDR, but the regulation is closely aligned with these EU regulations. This means that organizations developing or using NMI must comply with clear requirements for:
- Technical documentation and evidence
- NMI labeling and NMI-ID for traceability
- Periodic safety reporting
- Appointment of a responsible person for regulatory compliance (PRRC)[1]
Our services and support
GBA Key2Compliance’s consultants work to support organizations in the process of assessing whether their products are subject to the NMI regulation.
Once this is established, they also assist with ensuring compliance, including classification, documentation, ongoing advice, and implementation of routines. The consultants have experience in medical technology and information systems and can help with:
- Classification and registration of NMI with the Swedish Medical Products Agency
- Preparation of technical documentation according to HSLF-FS 2022:42
- Implementation of quality management systems and safety procedures
- Support during supervision and reporting
- Strategic advice regarding the distinction between NMI and medical devices
We know that every organization has unique needs—whether you are a municipality, region, authority, or private actor. With our experience and understanding of the regulations, we help you navigate correctly and avoid pitfalls.
For more information, you can also read more on the Swedish Medical Products Agency’s website: lakemedelsverket.se [1]
Do you need support with your NMI project?
Contact us for a free needs analysis — we help you ensure that your systems meet the requirements and contribute to safer care.