Evnia
Ensuring Clinical & Regulatory Compliance From The Get-Go

Ensuring compliance is of utmost importance in the medical device industry – to fortify an organisation’s position, advance patient safety, and bolster resilience. In the past, compliance was perhaps a box-ticking activity, with the focus on meeting the minimum requirements of regulatory bodies rather than going above and beyond to improve the safety and efficacy of devices. It was once considered a chore, instead of an opportunity for innovation and improvement.

Evnia is revolutionising compliance with a proactive regulatory approach that goes beyond ticking boxes. Unlike the old perceptions that considered regulatory as a bureaucratic red tape, Evnia views compliance as a powerful tool to improve device performance and safety profile while protecting manufacturers from regulatory risk, thus gaining a competitive edge.

A strategic compliance partner, Evnia helps medical device manufacturers that develop medical devices (MDs) and in-vitro diagnostic devices (IVDs) by providing a comprehensive regulatory and clinical affairs strategy and implementation package, from as early as the R&D phase. This proactive approach aids manufacturers in navigating the regulatory landscape efficiently, resulting in significant time and resources savings, and improved overall performance.

“Our core value proposition centres around our subject matter expertise within the regulatory and clinical field in Europe and the U.S. Evnia has actionable know-how in regulatory and clinical affairs and real world evidence (RWE), while operating our own clinics (Evnia-Clinics) makes us the only service provider that has such in-depth outreach the field,” says Dr. Efstathios Vassiliadis, CEO of Evnia.

One-Stop Compliance Destination for Global Companies

Medical devices that are imported into the European Union, including those from the UK following Brexit, must comply with the necessary regulations before they can be distributed or sold. Evnia ensures those manufacturers adhere to safety and regulatory standards.

To facilitate this, Evnia has a dedicated authorised representative service (AR) who represent the manufacturer in all interactions with EU competent authorities according to EU/MDR and EU/IVDR (2017/745 & 756 Regulations). Similarly, Evnia is offering the United Kingdom Responsible Person (UKRP) to fulfil the UK requirements according to MHRA, as those have been developing post Brexit. The AR and UKRP roles are crucial and, in many ways, mirror each other in function, as they are a point of contact between the manufacturer and regulatory authorities in the EU and UK and among other responsibilities conduct appropriate conformity assessments based on the available technical documentation.

Evnia’s AR and UKRP teams comprises highly skilled regulatory specialists and resources who facilitate the efficient management of a device’s entire lifecycle, resulting in faster time-to-market.

From Strategy to Implementation: A Journey without Hindrance

Evnia’s goal is to support medical device manufacturers in fulfilling the necessary regulatory and clinical compliance demands in the U.S. and Europe. This is particularly significant in light of recent regulatory changes that have introduced various complex and time/resource intensive considerations.

For instance, the introduction of the EU MDR was a major change in Europe’s medical device manufacturing industry, affecting every stage of a device’s lifecycle, from development to post-market surveillance.

The proactive introduction of clinical considerations and activities from as early as design phase, as well as proactive gathering and analysis of Real World Evidence throughout a device lifecycle is a reality that all manufacturers must embrace and perform. Evnia is stepping up to these changes by providing an evidence-based approach to clinical and regulatory actions to manufacturers based in order to “right-size” those activities and fulfil the regulatory expectations.

Unlike past perceptions considering compliance a bureaucratic red tape, Evnia views compliance as a powerful tool to improve innovation, performance & safety, and ultimately as a source of competitive edge

Clinical evaluation reporting (CER) services form the next important pillar of Evnia’s essential support to medical device manufacturers. CER services involve scoping and planning a comprehensive clinical evaluation plan, conducting a thorough review of clinical data, identifying gaps in data, conducting clinical data analysis, and creating and updating clinical evaluation reports with coherent post-marketing surveillance (PMS) and post-market clinical follow-up (PMCF) actions. During the last seven years, Evnia has successfully conducted more than 450 CERs most of which successfully passed EU/MDR scrutiny, a milestone that signifies the industries and notified bodies trust to our collective work.

Clinical evaluation is an ongoing and proactive process aimed at collecting evidence to support the safety and performance of medical devices. And it is this exact continuous process, which creates a key value for our services. Namely, Evnia focuses on providing life-cycle management services for the devices in the area of Clinical and Regulatory affairs, instead of a one-off service.

A Collaborative Approach to PMCF: Collecting Robust Real-World Clinical Evidence

PMCF is a critical component of Evnia’s clinical evaluation process as it involves the proactive gathering data on the device’s performance and safety after being launched in the market. This data is crucial to provide an updated risk/benefit profile of the device and drives the CER updates and crucially clinical activities, ultimately ensuring the device continues to be safe and effective.

The EU-MDR places greater emphasis on the proactive collection and analysis of RWE to provide objective evidence for medical device performance and safety within regulatory frameworks and in turn to support regulatory decision-making.

Evnia’s PMCF process begins with identifying the client’s unique PMCF requirements through developing its CER and thus developing a suitable strategy based on the device’s existing risk/benefit gap on clinical data. The detailed process includes gaps in documentation, or consistency of claims as well as technical documentation areas of non-compliance. The goal is to create a comprehensive PMCF plan that is based on current clinical evidence and reflects the device risks. Hence, Evnia is focusing on a step-wise approach in gathering data based on all available PMCF sources, starting from Surveys, clinical experience, registries, and investigations.

“At Evnia we focus on creating value by planning activities that make sense and not just plan the most time consuming and resource intensive activity from day one, This is an essential step as it helps manufacturers collect the right data to meet their objectives and optimise their resources, resulting in reduced cost and time to compliance ,” says Dr. Vassiliadis.

The first step of PMCF activities involves clinical surveys and clinical experience data, which provide the basic level of proactive evidence. The next level of clinical data collection focuses on the clinical registries conducted in clinical settings. For the highest level of evidence, clinical investigations are required, which can be time- and resource-intensive. The key differentiator here is that unlike a CRO, Evnia can conduct those activities in its own clinics, hence there is unparallel level of vertical integration and process control.
By providing such robust real-world clinical evidence, Evnia helps medical device manufacturers strengthen their position in the regulatory market, which is essential for obtaining and maintaining post-market approval for their devices. Its step-by-step collaboration with clients throughout the data collection process also enables manufacturers to demonstrate the safety and effectiveness of their devices, increasing the likelihood of market success.

Driving Client Success with Compliance and Clinical Strategy Expertise

Evnia’s success story is a testament to its competency in the regulatory and clinical affairs field. There are many success stories to share, yet there are two parallel ones that worth sharing as they developed at the same time. A manufacturer based in Denmark and another in the U.S. were not up-to-date with their clinical documentation, and so their regulatory documentation and clinical evidence level were falling behind.

Evnia has been working closely with both cases for the last three years, successfully passing audits and securing EU MDR approval. Building on this success, it also developed an effective PMCF strategy for their activities, which provided a compelling narrative to the auditors about the company’s ability to provide the necessary studies and data within the required timeframe for EU MDR compliance.

Evnia not only created the regulatory documentation but also implemented an entire clinical strategy and program for PMCF in both cases. This approach ensured all necessary data was gathered within the set timelines, which enabled the client to secure approval for all their devices under EU MDR. This demonstrated the effectiveness of Evnia’s approach and the unwavering dedication of its team to deliver the best possible outcomes for clients.

A Filotimo-Based Approach toward Regulatory Compliance

Evnia’s unique and comprehensive approach to regulatory compliance, rooted in the Greek concept of ‘filotimo,’ embodies the values of honesty, credibility, and a desire to serve society.

The team’s motto, ‘To Strive, To Seek, To Find,’ pushes it to be a reliable partner to MD and IVD manufacturers throughout their device lifecycle, accelerating innovation in the medical industry and making a substantial impact on patient care and quality of life. With its personalised solutions, deep expertise, and innovative strategies, Evnia has become a trusted partner for medical device manufacturers while navigating the complex and constantly evolving regulatory landscape of the EU.