Evnia

Evnia was founded in Denmark in 2015, envisaging to use regulatory compliance as a tool to accelerate healthcare innovation and to improve quality of care and life for patients. At the time, the EU Regulations 2017/745 & 746 (MDR/IVDR) were something more of rumour and nothing indicated the shift the MedTech/Biotech industries would see in the years to come.

Evnia was founded by people, who, having spent decades in international Regulatory and Clinical Affairs of medical devices (MDs), were familiar with the cascade of events that revealed the chronic vulnerabilities of the Directives, and which called for changes in the CE-marking process in Europe. Therefore, the need for consistent conformity assessments, transparency, traceability, and dynamic, lifetime-long post-market surveillance (PMS) did not come as a surprise and were part of Evnia’s agenda before the new European Regulations dictated their new and upgraded role in the approval of MDs.

Within this context, Evnia developed an ecosystem of services for the proactive management of complicated, international regulatory projects. At Evnia, we do no treat manufacturers and their portfolio as transit passengers who must be ‘’handled’’. Nor are we bludgeoned into offering consulting services by any flavour-of-the-day political or business correctness. The ‘’Evnia way’’ of doing things involves open, honest discussions, and a holistic gap assessment of the target device’s status quo and claims. Starting from the early development stages, we look into the concept, feasibility, and verification of devices, before moving to the final validation and evaluation of clinical development strategies. To enable manufacturers to achieve and maintain compliance with international regulatory requirements, we act as translators. We translate the manufacturer’s claims into regulatory requirements and then link these requirements to tangible actions and strategies.

While working to deliver high-quality Clinical Evaluation Reports (CER) and Technical Documentation (TD), Evnia knew that sooner rather than later, the industry would need to focus on the proactive PMS requirements, and more specifically, the Post-Market Clinical Follow-up (PMCF) activities. The proactive generation and collection of real-world clinical data (RWD) is at the heart of the new European Regulations but is also a significant, emerging contributor to global regulatory approvals. Although the underlying challenges in terms of standardization, credibility, quality, and validity are still issues of debate, the integration of RWD into PMCF strategies helps inform regulatory and clinical decisions with clinical data that cannot be collected via conventional clinical research activities.

Evnia has been a pioneer when it comes to using RWE-focused services to meet PMCF requirements. Our RWE Department has four distinct branches (Surveys, Registries, Clinical Investigations, and Clinical Experience Data) all aiming to bridge the gap between patient journeys and the lifelong regulatory requirements for MDs, in terms of clinical validation and PMS.

It is important to understand that PMCF strategies are like fingerprints; there can be no identical PMCF activities as there can be no identical clinical gaps. Even among equivalent devices, differences in terms of available clinical evidence highlight the need for customized actions. At Evnia, our PMCF process takes into account the interactions between regulatory processes. We favour the development of PMCF strategies that do not only take into account a device’s clinical evaluation but also user requirements, design features and risk management. Remediation of the clinical gaps emerging from the clinical evaluation indeed precedes finalization of PMCF planning and guides the decision for optimal activities. But in Evnia, we don’t want to lose sight of the big picture, i.e., the inherent risks, potential design changes, the future extension of indications, the global regulatory needs of a device throughout its lifetime. PMCF activities are customized to address the device-specific needs (in terms of population, indications, clinical claims etc.), while taking into account the manufacturer’s resources and business-like limitations (or ambitions). When it comes to the generation of PMCF data, there is not ‘’one ring to rule them all’. This is why Evnia’s multifaceted approach and embedment of RWD in PMCF activities enables the continuum between patient safety and market surveillance. The growing use of real-world evidence (RWE) contributes to quantifiable outcomes and therefore fulfils Evnia’s primary goal - to improve access to care by enhancing diversity of monitored populations and promoting healthcare innovation. In practical terms, this means that a manufacturer has the potential to choose from a pool of four different, standardized activities, which can support stand-alone or simultaneous clinical development objectives.

Evnia’s primary goal is to improve access to care by enhancing the diversity of monitored populations and promoting healthcare innovation.

Our full-value-chain services are supported by a growing, multidisciplinary, multinational and multicultural team of in-house medical writers, medical doctors, usability, risk, and validation engineers, biostatisticians, biocompatibility experts, and regulatory affair executives. It is our team of experienced, dedicated professionals that enable the implementation of tailored, timely, and cost-effective solutions. Evnia’s ecosystem has been designed to operate under advanced project management techniques and functions within a thorough, step-by-step review system to meet both the manufacturers’ and Authorities’ requirements. Evnia team members are supported by project and documentation management tools, ensuring audit and inspection readiness. However, none of this would make a difference without our ‘’translation experts’’, that is, our team members who accompany manufacturers along their regulatory journey by proposing realistic solutions and alternative routes of regulatory action. When it comes to PMCF-related projects, the above competitive advantages are crucial for ensuring data integrity and protection.

Evnia is headquartered in Denmark, with offices in London, Thessaloniki (Greece) and Siena (Italy), servicing life-science clients globally. Our cluster of services is constantly growing and currently includes:
• Authorized Representation Services
• Technical & Medical Documentation
• Clinical/Performance Evaluation Reports (CER/PER)
• Post-Market Clinical Follow-Up (PMCF) Strategy
• Clinical Development Strategy
• MedTech Project Management
• International Regulatory Affairs
• Quality Assurance
• EVA: Evnia Vigilance Algorithm
• Real-World Evidence (RWE): Surveys, Registries, Clinical Experience Data

We are paving a path that leads to timely regulatory compliance, risk minimization, and risk-control readiness. First and foremost, we remain an investment-orientated corporation that acts as the missing link between investors, regulators, and international healthcare innovators!