Cuviva receives MDR certification - paves the way for international growth

The entire team at Cuviva AB is very proud to share that the Cuviva RPM Platform is now certified according to MDR Class IIa. This makes Cuviva RPM Platform one of the first complete platforms certified according to MDR Class IIa for Remote Patient Monitoring and Hospital at Home. The certification demonstrates increased patient safety and efficiency of healthcare, and opens up for further extensive development.

Safe and Secure Medical Device Software

The new EU Medical Device Regulation (MDR), which entered into force in May 2021, involves comprehensive changes in the requirements for medical devices and medical device software. The motive of the new regulation is increased patient safety and increased requirements to demonstrate the clinical benefit of the product.

Cuviva Remote Patient Monitoring (RPM) Platform 3.1 is one of the first complete software platforms certified according to MDR Class IIa. This provides healthcare providers with assurance of high-quality software and increased patient safety when moving healthcare into the patient’s home. Cuviva’s platform is the complete Remote Patient Monitoring platform paving the way for Virtual Wards and Hospital at Home.

"Cuviva has the largest number of customers, the most complete software platform, and greatest width of application for Remote Patient Monitoring and Hospital at Home in Sweden, our home market. We are also a leader in the European market. I’m very proud of how we, in close cooperation with our customers, have developed the Cuviva RPM Platform over the past six years. The positive feedback and praise we receive from our customers is very rewarding. We can provide them with the most complete platform for digital transformation in setting up virtual wards.
The MDR Class IIa certification of Cuviva RPM Platform provides customers with additional safety and security for both patients and healthcare providers. It shows that the Cuviva platform has been externally reviewed and approved as medical device software. The certification will also open to cooperation with Pharma and MedTech Companies. Cuviva is at the forefront in the digitalization of healthcare with focus on those with the greatest need” - Henrik Cederqvist, CEO and Co-founder of Cuviva.

Enabling Digital Transformation of Healthcare

With an aging population there is a great need to move healthcare from the healthcare facilities into the patients’ homes. Patients experience both a greater sense of security and a closer connection to their healthcare provider through the combination of digital interactions and physical meetings. The Cuviva RPM Platform enables the healthcare providers to set up Virtual Wards and to monitor patients remotely. Examples of areas of use for Remote Patient Monitoring where the benefits are most immediate are heart failure, COPD, hypertension and diabetes. Cuviva RPM Platform also provides caregivers with tools for collaboration and decision support enabling them to focus on the patients with the greatest needs.

"When patients' symptoms and health status can be monitored regularly in their everyday life - from the comfort of their own home - they are usually more engaged and motivated to participate in their own care. For caregivers, it is easier to see the changes in patients' health and be able to act on these changes. The benefits of Remote Patient Monitoring and Hospital at Home are seen immediate for those patients with the greatest needs, for example patients with multimorbidity and frail elderly. Healthcare becomes proactive instead of reactive, which results in both increased quality of care and increased cost efficiency by applying a Virtual ward concept with support of Cuviva’s platform. Over time, this will lead to increasingly healthier individuals and less stressed healthcare staff. The reassuring of patients and healthcare staff originating from the possibilityto use an MDR-certified platform is very important to our customers.” - Alex Jaranka, Chief Medical Officer at Cuviva.

Stricter Regulatory Requirements

The MDR imposes stricter requirements on medical device software with more software falling into Class IIa and higher as compared to the previous Medical Device Directive. With this classification the medical device is required to be certified by a Notified Body. Any medical device software that is intended for diagnostic decisions or therapeutic purposes, or that monitors vital parameters is categorized according to Class IIa or higher. Thus, Remote Patient Monitoring Software and software for Hospital at Home must be MDR-certified according to Class IIa or higher.

"It has been extensive and purposeful work for a long period of time to reach the point where the Cuviva RPM Platform now is MDR Class IIa certified. We are very proud to have passed this milestone. For more than two and a half years, we have worked to demonstrate that Cuviva's platform is both safe and that it creates the opportunity for healthcare providers to increase the quality and efficiency of care through the use of the platform. This has been proven with clinical evidence demonstrating that use of the Cuviva RPM Platform reduces the number of hospitalizations and improves the patient's perceived quality of life. The certification process has been carried out through thorough review by the Notified Body BSI Group. We chose BSI Group since they are based both in the EU and UK making us well prepared for the upcoming UKCA certification. An important part of the process has been to identify which MDR class the solution should be assigned. According to us at Cuviva, external expert consultants, and the BSI Group, software for Remote Patient Monitoring and Hospital at Home requires a CE marking of Class IIa. This also requires the company to have a Quality Management System certified according to ISO 13485, which Cuviva has had in place for more than a year." - Stefan Jernberg, Chief Regulatory Officer at Cuviva.

An opportunity for extensive further development

For all software intended for Remote Patient Monitoring and Hospital at Home that is not yet MDR-certified, the MDR's transition rules apply. Medical Device Software that was certified under MDD before May 2021 can continue to be used until May 2024. However, this with the major limitation that significant changes may not be implemented to such software as long as they continue to live under the transition rules. All novel software for Remote Patient Monitoring and Hospital at Home, released after May 2021, must be certified according to the MDR directly. Hence, the transition rules do not apply for these.

"The Cuviva RPM Platform is already the Remote Patient Monitoring and Hospital at Home platform with the greatest width and depth. But in order to even better support healthcare providers in the digital transformation of moving healthcare home, even more is required. Both concerning additional functions in the platform and integrations with other external systems. With our MDR certification, we can now finally increase the pace of development of new functionality even more. As long as you live under the transition rules, you cannot rebuild the solution or add new functionality that is a significant change. However, as a consequence of our MDR certification, we can now implement such significant changes in our technical platform, which will deliver even greater value to our customers. This is so rewarding!" - Joakim Wingård, Chief Technology Officer at Cuviva.

What is MDR?

• The new European Union Medical Device Regulation (2017/745/EU) specifies requirements for medical devices that are used in the EU. The regulation has been legally binding since May 2021.

• Most medical device software, including all Remote Patient Monitoring and Hospital at Home solutions, must now be certified as Class IIa, which requires much more distinct evidence of clinical validity, safe design, and quality control from the manufacturer, compared to previous legislation.

• The new legislation aims to unify the regulation in the EU area and further improve patient safety.

• Devices that meet the previous requirements under the MDD, but do not meet the MDR requirements, can only be used until May 2024. However, for significant changes to these products and releasing new functions, CE marking is required according to the MDR.

For more information, contact

Henrik Cederqvist, CEO and Co-founder, henrik.cederqvist@cuviva.com, +46 708 24 33 87.