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Medixine Suite platform for remote patient monitoring now has the MDR-compliant CE IIa marking

Medixine Suite became one of the first MDR-compliant software platforms for remote patient monitoring in August 2022. Medixine Suite helps to improve the quality of care and cut off unnecessary manual work from healthcare professionals, leaving them with more time to focus on the patient.

High quality has always been a fundamental value for Medixine. This August our remote monitoring platform Medixine Suite was certified as a CE-marked Class IIa medical device under the EU regulation 2017/745 (MDR) for medical devices.

The audit for the certificate was conducted by notified body TÜV SÜD in Germany, one of the world’s best-known inspection and product certification services companies. Even though the auditing process is time consuming and demanding, Medixine welcomes the additional focus it brings on the quality of medical devices and software.

The previous EU regulation was from 1993, and it was long overdue for an overhaul. A large portion of modern medical devices contain software and are connected to IT systems that provide healthcare professionals with the information they need to provide care for their patients. If devices do not function appropriately, lives may be in danger. Modernized regulation ensures that more high-quality devices are on the market, providing peace of mind to both healthcare professionals and patients,” says Lasse Rousi, CEO of Medixine.

New MDR legislation challenges manufacturers

The new Medical Device Regulation (MDR) has been applied in EU- and ETA countries since May 2021. MDR replaced the previous Medical Device Directive (MDD), and the new legislation has raised criticism in the healthcare technology industry. It has been seen as a roadblock to innovation and product development since the time-to-certification with MDR-designated notified bodies is taking 13-18 months on average. This is double the time historically needed for certification under the directives.

MedTech Europe recently reported1 that only 15 % of the existing 500 000 medical devices are holding a CE certificate under the new legislation.

“We wanted to start the auditing as soon as possible. It’s important to us that our customers can always trust that our services meet the legislative standards. Being able to regularly bring new functionalities to the market is also an essential part of our high-quality customer service,” Rousi says.

Remote patient monitoring improves treatment

Medixine Suite is a software platform that extends patient monitoring outside hospitals. It allows a healthcare unit to focus on the patients who need care the most, while others can be monitored from their homes. Typical use cases are for example the care of patients with chronic diseases like COPD, CHF, or high blood pressure.

Medixine Suite has all the tools needed in remote care and secure communication between healthcare professionals and patients.

“When patients’ symptoms and state of health can be monitored regularly in their everyday life – from the comfort of their own home – they are usually more committed and motivated to participate in their own care. For medical professionals, it’s easier to see the changes in patients’ health and make conclusions. This will eventually lead to healthier individuals and less stressed professionals”, says Medixine’s Medical Director, MD, PhD Timo Hänninen.

Greater value with co-development

Medixine has a long tradition of co-development with customers and partners. Developing the solutions in close cooperation with the users brings value that couldn’t be reached any other way.

”With Medixine’s platform, we have been able to achieve our mission – providing telehealth with a human touch. The platform is very easy to use, and it allows for configuration to match our business needs. The whole system with remote monitoring devices works reliably”, says Clinical Management Centre Manager Sandra Guedes from Linde Healthcare in Portugal.

What is MDR?

  • The new European Union Medical Device Regulation (2017/745/EU) applies requirements for medical devices that are used in the EU. The regulation has been legally binding since May 2021.
  • Many devices, including remote monitoring solutions, must now be certified as Class IIa devices, requiring significantly more proof of safe design and quality control from the manufacturer.
  • The new legislation aims to unify the regulation in the EU area and further improve patient safety.
  • Devices that meet the earlier demands but not MDR can be used only until May 2024. Improving those products and releasing new features requires CE-marking under MDR.

1 MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation, July 2022

Want to learn more about MDR’s effects on your organization? Get in touch with the experts of our sales team!

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