Isansys Lifecare Achieves Certification Under European Union Medical Device Regulations

Isansys Lifecare, a company dedicated to improving lives with the use of technology, has become one of the first wireless patient monitoring manufacturers to successfully achieve certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).

The EU MDR certificate has been issued for the Patient Status Engine (PSE), the first product of its kind from a UK manufacturer to acquire this stringent level of certification for market entry in Europe and other countries who recognise this very high standard. The PSE has achieved the EU Quality Management System Certificate (CE Mark) following in-depth assessment of its revised Quality Management System, EU Technical Documentation and Clinical Evaluation, from its Notified Body, BSI. 

Julian Jones, chief compliance and regulatory affairs officer at Isansys, said: "Achieving MDR certification is a very important milestone for Isansys and is the result of our early adoption of the new and more stringent regulatory requirements in Europe. 

"This certification of our QMS under the MDR allows us to continue with the development and approval of our new products in accordance with current EU regulations ensuring both safety and performance of devices for their intended clinical application. This is a company-wide achievement, and it wouldn’t have been possible without the extensive and diligent work of the entire Isansys Lifecare team. This approval now allows Isansys to continue on its stated goal to provide safer care to patients everywhere.”

Keith Errey, CEO at Isansys, said: "Without doubt, the MDR has raised the standards for medical device regulation and we are excited to be one of the first medical device companies to receive MDR certification. This allows us to adhere to our most important goal of making the patients and our customers our first priority by providing medical devices of the highest quality. We are now poised to take great leaps forward in their technology needs.”

The Medical Device Regulation (EU 2017/45) went into effect in May of 2021 for all manufacturers, distributors, and users of medical devices in the EU, replacing the prior Medical Device Directive. In comparison to the previous directives, the MDR is intended to establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovative companies, like Isansys. As such, most companies selling products in the EU have had to make significant improvements to documentation, technical testing, and clinical evaluation of their medical devices in order to comply with the new MDR. Notably, given the amount of work required, Isansys is one of the first manufacturers of a remote patient monitoring platform to receive QMS certification under the MDR in the United Kingdom.