Fimea to investigate the conformity of software-based medical devices

Fimea will conduct a targeted market surveillance campaign  for software-based medical devices during 2025. As part of its market surveillance, Fimea will conduct a review of  health care software available on the Finnish market. 

The market surveillance campaign will begin with a survey sent to software sector operators, which will be used to examine their knowledge of regulation and the regulatory status and compliance of health care software. The survey will be sent by the end of June, and responses to the survey must be submitted by 22 August 2025. 

Based on this review, an effort will be made to identify any non-compliances and to target guidance and enforcement measures, such as inspections, to these operators.  The information obtained during the review will be utilised both in the development of market surveillance and in the general guidance and advice provided to software sector operators. 

The aim of the project is to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on the EU market meets the requirements set for it. 

What kind of software are medical devices? 

Software manufacturers sometimes find it difficult to identify when software is a medical device. For this reason, Fimea wants to increase the awareness of manufacturers and other operators in the sector and the guidance provided to them, and to ensure that software marketed as medical devices have a CE marking and are compliant. 

An independent piece of software (stand-alone software) can be a medical device if it is involved in such things as diagnosis, treatment planning, or monitoring. In this case, the software must meet the requirements for medical devices as defined in Regulation (EU) 2017/745 (MDR) or those for in vitro diagnostic software as defined in Regulation (EU) 2017/746 (IVDR). The purpose of these regulations is to ensure the safety and performance of devices throughout their life cycle. 

What types of software does Fimea’s market surveillance report focus on and what information will be collected? 

To carry out a market surveillance study, Fimea will approach Finnish health care software manufacturers whose products are registered as medical devices in the European EUDAMED database or whose products could be medical devices based on the company’s marketing. 

During the study, manufacturers will be asked for more detailed information on the intended purpose of their software and its functions to ensure its regulatory status. 

The review seeks to obtain information on the basis of which the intended purpose and risk classification of the software can be assessed as can whether its conformity assessment has been carried out in accordance with the  risk class. The review also aims to ensure that if the software complied with the EU directives on medical devices or IVDs that were previously in force, manufacturers have identified the stricter obligations introduced by the current EU regulations and, if necessary, also complied with the conditions laid down in transitional provisions. 

Software as a medical device 

Is your software a Medical Device infographic (PDF)  

MDCG 2019-11 rev. 1 Qualification and classification of software guideline (PDF)  
 
The MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices provides additional information on the classification of IVD software (PDF)