CDSA

Irdeto and confinis will provide medical device companies a comprehensive toolkit to determine the regulatory readiness of their medical devices.

As part of the partnership, Irdeto and confinis will launch a web-based assessment tool enabling medical device providers to examine their cybersecurity and regulatory preparedness under the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR).

The MDR went into effect in May 2021, introducing various changes for medical device manufacturers and distributors after a four-year transition period. Recent Irdeto data revealed that while 80% of medtech executives believe that regulatory compliance is the biggest business benefit of implementing a strong cybersecurity strategy, only four in 10 respondents rated themselves very aware or knowledgeable about forthcoming EU and US cybersecurity regulations.

“Providing extensive regulatory expertise, resources and tools is critical to the success of medtech companies. Protection of connected medical devices as well as the information of providers and patients that use them is essential. With our long heritage securing over six billion devices and apps worldwide, we bring strong technical acumen and healthcare industry knowledge as well as deep experience in helping our customers safeguard their software and medical devices from vulnerabilities and cyberattacks,” said Steeve Huin, CMO and Head of Business Development and Strategic Partnerships at Irdeto. “confinis is unmatched in the regulatory compliance field, and we are excited to partner with them to bring customers an offering that encompasses both technical and top-notch regulatory expertise so they can launch their products with complete confidence. Together, we are making the medical devices industry stronger and protecting patients from cyberattacks that could negatively affect their health and wellbeing.”

Irdeto provides modular cybersecurity solutions and services to medical technology and telehealth companies. With 50+ years of experience securing digital products and platforms and an extensive patent library of security technologies, Irdeto’s field-tested product portfolio enables healthcare companies to identify vulnerabilities, proactively respond to emerging threats and comprehensively protect patient medical information, user safety and security.

confinis has worked with close to 500 customers on five continents, including dozens of start-ups. The organization has significant expertise on global regulatory affairs and in particular the EU’s MDR and IVDR, having consulted on over 2,000 medical devices and 200 combination products.

This partnership is a first for the industry and will provide IoMT customers with a comprehensive toolkit of cybersecurity and regulatory expertise needed to ensure their medical devices and software are ready for CE (Conformitè Europëenne) marking in Europe under the MDR and the IVDR. As part of the toolkit, customers will have access to a web-based tool that will guide them through a series of questions to determine their readiness for MDR and IVDR. Once completing the assessment, they will be provided with a response and any recommended next steps.

“Healthcare executives are experts at providing patient care and need support on ensuring their devices are secure and ready for certification – that’s where we come in,” said Andrea Biasiucci, PhD, Competence Cluster Lead and Head of Digital Health at confinis. “The combined expertise of confinis and Irdeto will bring unparalleled cybersecurity and regulatory capabilities to medtech customers. We are thrilled to join forces with the Irdeto team to support the healthcare community in ensuring their connected medical devices are safe, secure and compliant.”