Software as a Medical Device (SaMD) under Medical Device Regulation (EU) (MDR) 2017/745
Medical Device Software Uncertainties
General Background
Under the European Union’s Medical Devices Regulation (EU MDR), software that meets the definition of a medical device is subject to the same regulatory requirements as other medical devices.
When it comes to the classification of medical device software, rule 11 of EU MDR states that if software is used to take decisions with diagnosis or therapeutic purposes or to monitor physiological processes, then it is classified as a class IIa medical device. If such decision can result in death or permanent deterioration of human health, then it is a class III medical device. If it leads to a serious deterioration of human health and/or surgical intervention due to e.g. monitoring important physiological parameters that are subject to variations leading to immediate danger for human health, then it is a class IIb medical device. In all other cases, software is a class I medical device.
The EU MDR provides specific requirements for software as a medical device (SaMD), which is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR, has laid out several steps that can aid in making the decision, as well as whether the device is a medical device or in vitro medical device. Classification depends on a couple of factors, such as software’s intended purpose, its operations, and whether it benefits individual patients.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
The manufacturer should address the collection and utilization of relevant sources including:
Some of the key requirements for SaMD under the EU MDR include:
- SaMD must be classified as a medical device under the EU MDR based on the intended purpose, risk, and other factors.
- Manufacturers must perform a conformity assessment procedure for SaMD that is appropriate for the device's classification. This may include a self-assessment, a third-party assessment, or a full quality management system audit.
- Manufacturers must identify, assess, and manage the risks associated with their SaMD, including cybersecurity risks.
- Considering MDCG 2020-1, manufacturers must perform a clinical evaluation of their SaMD that takes into account the intended use, valid clinical association, technical performance, clinical performance of the device.
- Manufacturers must establish a post-market surveillance system for their SaMD to monitor performance, identify and report incidents, and implement corrective and preventive actions.
- Manufacturers must ensure that their SaMD is transparent and traceable throughout its lifecycle, including the development, testing, and maintenance phases.
- SaMD must be accompanied by appropriate labeling and instructions for use that provide clear and accurate information to users and patients in consideration of MDCG 2019-16.
In summary, SaMD is subject to the same regulatory requirements as other medical devices under the EU MDR. Manufacturers must comply with these requirements to ensure the safety and effectiveness of their SaMD and to obtain the necessary approvals to market their products in the European Union.
Our Services
Training
AKRA TEAM can provide training in order to understand the relevant legal framework related to medical device software (SaMD) laid out in relevant regulations, standards, and directives.
Process and Templates Development
AKRA TEAM has proven procedure and document templates available for all aspects of developing and supporting SaMD technical documentation.
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of SaMD technical documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write all aspects of SaMD technical documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to address the needs of any manufacturer.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of technical documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU MDR and EU IVDR.
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