Software as Medical Device
Medical device certification
Unlock the Future of Healthcare with Evidencio's Medical Algorithm Certification
Find in Evidencio your trusted supplier
Enabling clinical use of AI Algorithms as certified Medical Devices in
Software as a Medical Device with Evidencio
In the rapidly advancing field of medical technology, ensuring the safety, efficacy, and compliance of your medical algorithms is paramount. Evidencio specializes in certifying medical algorithms as medical devices, resulting in Software as Medical device (SaMD), giving you the necessary credentials to excel in the competitive healthcare market.
Using algorithms, prediction algorithms, nomograms, etc. for clinical decision support is subject to strict regulations (currently particularly so in the EU). In the context of the EU MDR (Medical Device Regulation) an algorithm, or any software tool, that influences medical decision making is to be treated as a Medical Device.
Algorithms that are intended to be used by healthcare professionals as decision aids generally qualify as class IIa or IIb medical devices under the MDR. This implies that these algorithms have to be CE certified before they can be used.
CE certification of class 2, class 3 medical devices can only be done by Notified Bodies, which means that the certification process and prerequisites are substantial and costly.
Evidencio has invested significant resources in streamlining this certification process. We can now provide an easy, sustainable and scalable way to be compliant in your use of algorithms and AI for clinical decision support, shared decision making, patient monitoring, etc. at a fraction of the cost & time.
Please contact us for detailed information on how we can facilitate getting your algorithm certified.
Does my algorithm need to be certified?
Medical Devices
The Evidencio Algorithm Medical Device Library caters to both algorithm IP-holders, as well as, Professional Algorithm users.
Medical Device Library for IP-holders
The Evidencio Algorithm Medical Device Library offers a unique and secure channel for you to offer and deploy your algorithm to the (clinical use) market (as a Medical Device). By using the Evidencio platform you can make use of our technology, network, interfaces and installed base in bringing your algorithm to market. Optionally, we can assist in transforming your algorithm into a MDSW.
How it works
- You implement your algorithm on Evidencio, or commission us to do so.
- You set the price that end-users need to pay in order to use your algorithm.
- Evidencio customers can subscribe to your algorithm.
- You receive your license fees, Evidencio receives a commission.
Medical Device Library for Medical Professionals & Hospitals
The Evidencio Algorithm Medical Device Library is a unique and trusted source for clinical/medical algorithms. It offers (CE-marked) algorithms with the stability and usability of the Evidencio Platform, as standard web-based algorithms, or EMR-integrated algorithms.
Evidencio users with a paid subscription plan can additionally purchase subscriptions for Algorithms from the Medical Device Library.
How it works
- You have a personal Evidencio-Pro subscription or an active hospital(-department) subscription.
- You select the algorithms you would like to use from the algorithm store.
- The selected algorithm fees will be billed to your subscription.
- You'll have access to the selected algorithms on the Evidencio platform and/or through the Evidencio API.
Please contact us if you have any questions.
Purposes of Medical Device under MDR & IVDR
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability.
- Investigation of, or replacement or modification of, anatomy or a physiological or pathological process or condition.
- Provision of information through in vitro testing of specimens from the human body, including organ, blood, and tissue donations.
Medical device algorithms in context of the EU AI-act
In addition to the MDR and IVDR medical AI Algorithms in the EU will have to comply with the EU AI-act. The AI-act takes a risk based approach in classifying the application of AI systems. The figure below shows some examples of the different risk levels as identified by the AI-act. Evidencio has identified the overlap of the applicable legislations and as illustrated in the figure below. Do not hesitate to reach out to us if you have any questions on this topic.
Evidencio SaMD Services
Medical Device certification is costly and time consuming. Evidencio has engineered a number of effective services that greatly enhance the efficiency and effectiveness of the underlying processes, re-using platform and TF-components. As such, we offer comprehensive QMS-as-a-service and Legal-Manufacturing-as-a-service solutions. Please visit our services page to find out more.