Many companies treat regulatory compliance like a final exam, cramming at the last minute to pull together the necessary documents. This reactive approach rarely works. A successful market submission starts much earlier, with a thoughtful clinical evaluation strategy that guides your product from its initial concept to post-market surveillance. This living document ensures that every decision you make during development is aligned with your ultimate regulatory goals. It forces you to think critically about your device’s claims and the evidence needed to back them up, turning compliance from a final hurdle into an integrated part of your product’s lifecycle.
Key Takeaways
- Start with a strategic roadmap: Your Clinical Evaluation Strategy is the essential blueprint that proves your device’s safety and performance, guiding every decision from initial design to post-market monitoring.
- Translate strategy into a detailed plan: Your high-level strategy sets the “why,” but the Clinical Evaluation Plan (CEP) defines the “how,” turning your vision into actionable steps for collecting and analyzing the right clinical evidence.
- Treat your evaluation as a living process: A successful strategy isn’t a one-time project; it requires ongoing collaboration across teams and must be regularly updated with post-market data to maintain compliance throughout your device’s lifecycle.
What Is a Clinical Evaluation Strategy?
Think of a Clinical Evaluation Strategy (CES) as the foundational blueprint for your medical device’s regulatory journey. It’s a detailed, proactive plan that outlines exactly how you will collect, appraise, and analyze clinical data to prove your device is safe and performs effectively. This isn’t just about paperwork; it’s about building a solid case for your product from the ground up.
What It Is and Why It Matters
At its core, a CES is your comprehensive game plan for demonstrating your device’s safety, performance, and clinical benefit. This formal document, often called a Clinical Evaluation Plan (CEP), serves as a roadmap for your entire clinical evaluation process. It specifies the data you need, where you’ll get it, and how you’ll analyze it to confirm that your device’s benefits outweigh any potential risks.
This matters because, first and foremost, it’s a regulatory mandate. The EU’s Medical Device Regulation (MDR), for example, explicitly requires a CEP. Beyond compliance, a well-defined strategy helps you avoid costly regulatory delays and setbacks. It forces you to think critically about your device’s claims early on, ensuring a smoother and more predictable path to market.
Its Role in Your Device’s Lifecycle
A Clinical Evaluation Strategy is not a one-and-done task. It’s a living document that plays a vital role throughout your device’s entire lifecycle, from initial concept to post-market surveillance. You should develop your strategy early in the product development process, as it directly informs critical documents like your device’s intended purpose and design requirements. This early planning ensures your development efforts are always aligned with your regulatory goals.
Once your device is on the market, the strategy continues to guide your work. The data and analysis are compiled into a Clinical Evaluation Report (CER), which must be regularly updated with new information gathered from real-world use. This ongoing evaluation ensures your device remains safe and effective for patients long after its initial launch.
Why Your Medical Device Needs a Clinical Evaluation Strategy
Think of your clinical evaluation strategy as the foundation of your medical device’s journey to market. It’s not just another document to file away; it’s a living game plan that proves your device is safe, effective, and ready for real-world use. A thoughtful strategy does more than just satisfy regulators—it protects patients, manages risk, and ultimately builds a trusted brand. Without one, you’re essentially navigating a complex regulatory landscape without a map. A strong strategy ensures every decision, from product development to post-market surveillance, is informed, intentional, and aligned with your end goal: a successful and compliant medical device. It’s your roadmap for gathering the right evidence to demonstrate that your device delivers on its promises.
Meet Regulatory Requirements
First and foremost, a clinical evaluation strategy is a regulatory must-have. Authorities like the FDA and European bodies require you to prove your device is safe and performs as intended. In the EU, for example, manufacturers must have a Clinical Evaluation Report (CER) to comply with the EU Medical Device Regulation (MDR) 2017/745. This report is the final output, but it starts with a solid Clinical Evaluation Plan (CEP), which outlines exactly how you’ll gather the necessary clinical data. This isn’t just about paperwork; it’s about creating a clear, defensible argument for your device’s approval and showing regulators you have a systematic process for evaluating its performance and safety throughout its entire lifecycle.
Prioritize Patient Safety and Manage Risk
At its core, the goal of a clinical evaluation is to demonstrate that your medical device is safe and effective for patients. Your strategy is the framework that guides this process. It helps you systematically identify potential risks and then gather the clinical evidence needed to show that the device’s benefits far outweigh them. A well-defined Clinical Evaluation Plan (CEP) details the strategy for assessing the clinical safety and performance of your device. This proactive approach to risk management is fundamental. It ensures patient safety is the top priority from the earliest stages of development, giving you, your stakeholders, and your future customers confidence in your product.
Build Credibility and Gain Market Access
A robust clinical evaluation strategy is your key to unlocking market access and building a strong reputation. When you present regulators with a clear, evidence-based case, it streamlines the approval process. A well-executed CER helps devices get approved faster and stay compliant, which builds trust between you and the notified bodies. This credibility extends to clinicians and patients, who are more likely to adopt a device with a proven track record of safety and efficacy. By creating a strong CEP from the start, you make critical decisions that influence everything from testing to your final submission, paving the way for a smoother path to market and long-term success.
What Goes Into a Clinical Evaluation Strategy?
A strong clinical evaluation strategy is your roadmap for demonstrating that your medical device is safe and performs as intended. It’s not just a box to check; it’s a living document that guides your device through its entire lifecycle. Think of it as the foundation upon which your regulatory submission is built. A well-crafted strategy systematically gathers and analyzes clinical data to prove your device’s claims, ensuring you have a clear and compelling story to tell regulators.
This process is formalized in a document called the Clinical Evaluation Plan (CEP), which details every step you’ll take. It brings structure to your efforts by breaking down the process into four key components: setting clear objectives, identifying your data sources, choosing your assessment methods, and planning your timeline. By carefully considering each of these areas, you create a comprehensive framework that not only satisfies regulatory bodies but also reinforces the safety and effectiveness of your product. This proactive approach helps you anticipate challenges and ensures your team is aligned and prepared for the path ahead.
Set Clear Objectives
Before you can gather any evidence, you need to know what you’re trying to prove. Setting clear objectives is the critical first step. This means defining your device’s intended purpose with precision. Who is the target patient population? What specific clinical conditions will it diagnose, treat, or monitor? What are the measurable benefits it provides? Your objectives should be specific, well-defined, and directly tied to the claims you make about your device. A Clinical Evaluation Plan (CEP) outlines these goals, ensuring they align perfectly with regulatory requirements and guide every subsequent step of your evaluation.
Identify Data Sources
With your objectives in place, the next step is to determine where you’ll get the data to support them. Your strategy should cast a wide net to identify all relevant clinical evidence. This includes data from clinical investigations of your device, scientific literature on equivalent or similar devices, and any available pre-clinical data. It also involves looking at post-market surveillance information, complaint data, and adverse event reports. A thorough benefit-risk analysis requires you to consider both favorable and unfavorable data to present a balanced and credible assessment of your device’s safety and performance.
Choose Your Assessment Methods
Once you know what data you’re collecting, you need a solid plan for how you’ll analyze it. This is where you define your methodology. How will you conduct your literature search to ensure it’s systematic and repeatable? What criteria will you use to assess the quality and relevance of each piece of data? Your plan should detail the specific methods for data collection, including the study design, patient population, and endpoints you’ll be evaluating. Having a robust and objective appraisal process is essential for building a convincing argument and demonstrating that your conclusions are sound and unbiased.
Plan Your Timeline and Milestones
Finally, a great strategy needs a practical timeline. A clinical evaluation is a significant undertaking, so breaking it down into manageable phases with clear milestones is key to staying on track. Your timeline should map out the entire process, from initial planning and literature searches to data analysis and the final drafting of the Clinical Evaluation Report (CER). Assigning deadlines for each stage helps you manage resources effectively and ensures your team is aligned. A well-structured timeline not only keeps your project moving forward but also helps you anticipate potential delays and prepare for your regulatory submission with confidence.
How to Develop an Effective Clinical Evaluation Strategy
Creating a clinical evaluation strategy can feel like a huge undertaking, but breaking it down into manageable steps makes the process much clearer. A thoughtful, well-structured approach not only satisfies regulatory bodies but also sets your medical device up for success from the very beginning. By focusing on your goals, collaborating with your team, choosing the right methods, and ensuring quality, you build a solid foundation for your entire product lifecycle. Think of these steps as the essential building blocks for a strategy that is both compliant and effective.
Step 1: Define Your Objectives
Before you can gather any evidence, you need to know what you’re trying to prove. Start by clearly defining the objectives for your clinical evaluation. What are the specific claims you want to make about your device’s safety and performance? Your goals will guide every other decision you make. This process is formalized in a Clinical Evaluation Plan (CEP), a document that outlines your entire strategy. A well-written CEP details your objectives, methodology, and risk-benefit analysis, creating a transparent and structured approach that regulators appreciate. Getting this right from the start saves you from costly revisions and delays down the road.
Step 2: Involve Stakeholders Early
Don’t develop your strategy in a silo. Bringing in key stakeholders from different departments—like R&D, quality assurance, marketing, and clinical affairs—early in the process is critical. Each team offers a unique perspective that can uncover potential challenges or opportunities you might have missed. For instance, your engineering team understands the device’s technical specifications, while your marketing team knows the claims they want to make. Engaging stakeholders ensures everyone is aligned on the objectives and the evidence needed to support them. This collaborative approach fosters a sense of shared ownership and helps streamline the entire evaluation process.
Step 3: Choose Your Data Collection Methods
With your objectives defined and stakeholders aligned, it’s time to decide how you’ll gather your clinical evidence. The methods you choose must directly support the claims you intend to make. Will a systematic literature review be sufficient, or will you need to conduct a new clinical investigation? Perhaps a combination of pre-market studies and post-market data is the best approach. Your Clinical Evaluation Plan should explicitly outline which methods you’ll use and why they are appropriate for your device and its intended purpose. Selecting the right data collection methods ensures the evidence you generate is relevant, robust, and convincing.
Step 4: Build a Quality Assurance Framework
The quality of your data is just as important as the quantity. A strong quality assurance framework is essential for generating reliable evidence that demonstrates your device’s safety and effectiveness. This framework goes beyond just collecting data; it involves thoughtful study design, clear protocols, and proactive risk management strategies. Your clinical evaluation should be guided by a plan that defines the patient population, study objectives, and endpoints. By building quality checks into every step, you ensure your data is credible and defensible. This is a key part of any guide to designing a CEP.
Which Regulatory Standards Guide Your Strategy?
Developing a clinical evaluation strategy isn’t about reinventing the wheel. It’s about following a clear, established map laid out by regulatory bodies and international standards organizations. These guidelines are designed to ensure that every medical device is safe, performs as intended, and genuinely benefits patients. Think of them as the rulebook for getting your device to market and keeping it there.
Your strategy must be built on a solid foundation of these requirements. Whether you’re aiming for the European market, the United States, or both, your approach will be shaped by specific regulations. Key frameworks include the EU’s Medical Device Regulation (MDR), expectations from the U.S. Food and Drug Administration (FDA), and globally recognized ISO standards. These standards aren’t just bureaucratic hurdles; they provide a structured path for demonstrating your device’s value and safety. Integrating them into your strategy from day one is essential for a smooth and successful regulatory journey.
EU MDR and MEDDEV Guidelines
If you plan to sell your medical device in Europe, the EU’s Medical Device Regulation (MDR) is your primary guide. This regulation sets a high bar for clinical evidence and documentation. A central requirement under the MDR is the creation of a Clinical Evaluation Plan (CEP). This document is your formal game plan, explaining exactly how you will gather the clinical data needed to prove your device is safe and effective. According to Article 61 and Annex XIV of the MDR, every manufacturer must have a CEP. It’s not optional. This plan guides your entire evaluation process, from data collection to the final analysis presented in your Clinical Evaluation Report (CER).
FDA Expectations and ISO Standards
In the United States, the FDA has its own set of rigorous expectations for clinical evaluations. While the terminology might differ slightly, the core principle is the same: you must provide sufficient evidence to support your device’s safety and performance claims. The FDA often aligns with international standards, which can help streamline your submission. Following globally recognized standards from the International Organization for Standardization (ISO) demonstrates a commitment to quality and can make your regulatory review process more predictable. A well-documented CEP is a critical tool for organizing your evidence and presenting a clear, compelling case to regulators on both sides of the Atlantic.
Integrate Risk Management (ISO 14971)
Clinical evaluation and risk management are two sides of the same coin. You can’t have one without the other. The international standard ISO 14971 provides the framework for applying risk management to medical devices. Your clinical evaluation strategy must be deeply integrated with this process. This means identifying all potential risks associated with your device, analyzing them, and evaluating whether the clinical benefits outweigh them. Your CEP needs to explicitly describe this risk-benefit analysis. It’s about proving not just that your device works, but that its positive impact on patients is worth any potential hazards.
Plan for Post-Market Follow-Up
Getting your device approved is a huge milestone, but it’s not the end of your clinical evaluation journey. Regulatory bodies, especially under the EU MDR, require continuous monitoring of a device’s performance after it launches. This is known as Post-Market Clinical Follow-up (PMCF). Your initial strategy must include a plan for how you will continue to collect data from real-world use. This information is used to regularly update your Clinical Evaluation Report (CER), ensuring it always reflects the current understanding of your device’s safety and performance. This ongoing process helps identify any new or unexpected risks and confirms that the risk-benefit balance remains positive over the device’s entire lifecycle.
Strategy vs. Plan: What’s the Difference?
It’s easy to use the words “strategy” and “plan” interchangeably, but in the world of regulatory compliance, they have distinct and important roles. Think of it like building a house. Your strategy is the architect’s blueprint—it shows the overall vision, the structure, and how all the rooms connect to create a functional home. Your plan is the contractor’s detailed schedule—it outlines who pours the foundation, when the framing goes up, and the specific materials needed for the plumbing. You need both the vision and the execution to succeed.
In the context of a clinical evaluation for your medical device, the same logic applies. Your strategy sets the direction and answers the big “why” and “what” questions. It’s your high-level approach to proving your device is safe and performs as intended. The plan, on the other hand, gets into the weeds. It details the “how,” “who,” and “when,” turning your strategic vision into a series of concrete, actionable steps. Understanding how they differ—and how they depend on each other—is fundamental to building a successful submission and getting your product to market. Without a clear strategy, your plan might involve a lot of busy work that doesn’t actually support your device’s claims. Without a detailed plan, your brilliant strategy remains just an idea on a whiteboard.
The Strategy: Your High-Level Approach
Your clinical evaluation strategy is your guiding philosophy. It’s the top-level thinking that defines the entire approach you’ll take to demonstrate your device’s safety and performance. This isn’t about day-to-day tasks; it’s about establishing the core logic that will justify your device’s place in the market. The strategy addresses foundational questions like: What is the main claim we need to support with evidence? What is the most logical and defensible way to gather that evidence for this specific device?
This high-level view considers your device’s classification, its novelty, and the associated risks. A guide to clinical evaluation often begins by defining this strategy, as it sets the stage for everything that follows. It ensures your efforts are focused, coherent, and directly aligned with regulatory expectations from the very start.
The Plan: Your Detailed Roadmap
If the strategy is the “what,” the plan is the “how.” This is where you translate your high-level approach into a detailed, documented roadmap. For medical devices, this is typically captured in the Clinical Evaluation Plan (CEP). The CEP is a formal document that outlines the specific steps you will take to execute your strategy. It leaves no room for ambiguity.
Your plan will specify the device’s intended purpose, the target patient populations, and the precise methods you’ll use for data collection and analysis. It also includes a benefit-risk analysis and establishes clear criteria for evaluating the data you collect. A comprehensive Clinical Evaluation Plan template will always include these granular details, ensuring that every member of your team knows exactly what to do, what data to look for, and how it will be assessed.
How They Work Together
A strategy without a plan is just an idea, and a plan without a strategy lacks direction. The two are completely codependent. Your strategy provides the essential “why” that gives your plan purpose, ensuring that the detailed actions you take are all contributing to the same overarching goal. The plan, in turn, makes the strategy achievable by breaking it down into manageable tasks and timelines.
This synergy is critical for regulatory success. A well-prepared Clinical Evaluation Plan serves as the bridge between your strategic vision and the practical work of gathering and analyzing clinical evidence. When regulators review your submission, they look for this clear connection. They want to see a logical strategy supported by a meticulous plan, demonstrating that you’ve thoughtfully and systematically proven your device’s safety and effectiveness.
How to Collect Strong Clinical Evidence
Your clinical evaluation strategy is only as strong as the evidence you gather to support it. The goal is to build a robust, convincing portfolio that demonstrates your device’s safety and performance from every angle. Relying on a single source of data is rarely enough; regulators want to see a comprehensive picture that leaves no room for doubt. This means combining different types of evidence to tell a complete and compelling story about your product.
Think of yourself as a detective, piecing together clues from various sources to build an undeniable case for your device. The methods you choose will depend on your device’s novelty, its risk class, and its intended use. A well-rounded approach often involves a mix of reviewing existing literature, conducting new studies, and analyzing data from real-world use. Each method offers a unique perspective, and when woven together, they create a powerful narrative that not only satisfies regulatory bodies but also builds deep trust in the market. This multi-faceted approach shows diligence and a commitment to patient safety, which is exactly what regulators and customers want to see. It’s about creating a body of evidence so thorough that it anticipates questions and provides clear, data-backed answers.
Systematic Literature Reviews
Before you can build your case, you need to understand the existing landscape. A systematic literature review is a structured, methodical search of all published clinical data relevant to your device. This isn’t just a quick keyword search; it’s a comprehensive process designed to find, evaluate, and synthesize all relevant studies. This review helps you understand the current standard of care, identify the performance and safety benchmarks for similar devices, and pinpoint any gaps in the existing evidence. The findings from a systematic review will inform your entire strategy, helping you decide if you have enough existing data or if you need to generate new evidence through clinical trials.
Clinical Trials and Post-Market Data
When existing literature isn’t sufficient to support your claims, you’ll need to generate your own data through clinical trials. These are carefully designed studies that assess your device’s safety, performance, and effectiveness in a controlled environment with human subjects. The different types of clinical research provide high-quality, reliable data specific to your device. But the data collection doesn’t end once your device hits the market. Post-market surveillance is a critical, ongoing process of gathering data from real-world use. This helps you monitor long-term performance, identify rare adverse events, and ensure your device continues to be safe and effective for patients over its entire lifecycle.
Real-World Data and Patient Outcomes
While clinical trials are the gold standard, they happen in a controlled setting. Real-World Data (RWD) gives you insight into how your device performs in the messy, unpredictable real world. This data is collected from sources like electronic health records (EHRs), patient registries, and insurance claims. Analyzing Real-World Evidence helps you understand long-term patient outcomes and can supplement the evidence gathered during pre-market trials. It provides a broader perspective on your device’s value and impact, which is incredibly valuable for both ensuring regulatory compliance and building market trust. This data helps you tell a story about your device’s performance beyond the clinical trial environment.
Registry Data and Comparative Studies
Patient registries are organized databases that collect uniform data on individuals with a specific disease or condition. This information can be a powerful tool for understanding how your device performs in a specific patient population over time. You can use registry data to monitor safety and performance trends. Another powerful method is the comparative study, where your device is directly compared to another treatment or the existing standard of care. These studies are essential for demonstrating that your device is not only safe and effective but also offers a tangible benefit over other available options. This kind of evidence is incredibly persuasive and can significantly strengthen your claims and market position.
Common Challenges to Prepare For
Developing a clinical evaluation strategy is a detailed process, and it’s smart to anticipate potential hurdles. Knowing what to expect can help you create a more resilient and effective strategy from the start. Most of the challenges come down to planning, communication, and having the right expertise on your team. By preparing for these common issues, you can keep your project on track and ensure your final report is solid, credible, and ready for regulatory review.
Managing Time and Resources
A thorough clinical evaluation requires a significant investment of both time and specialized personnel. One of the biggest challenges is simply underestimating the resources needed. It’s not just about budget; it’s about having people with the right training to conduct literature searches, analyze data, and write the report. You also need to balance input from multiple departments, which can be time-consuming. A realistic project plan that accounts for the necessary hours and helps you find the right people is your best defense against delays and budget overruns.
Handling Different Market Regulations
If you plan to sell your medical device in multiple countries, you’ll face a complex web of different regulatory requirements. The expectations of the FDA in the United States can differ significantly from the EU’s Medical Device Regulation (MDR). A strategy that satisfies one regulatory body may not be sufficient for another. This means your team needs a deep understanding of the specific nuances of each target market. Creating a core evaluation that can be adapted for different regions is key, but it requires careful planning to ensure all global regulatory compliance standards are met without duplicating effort.
Ensuring Data Quality and Coordination
The strength of your Clinical Evaluation Report (CER) rests entirely on the quality of your supporting data. A common challenge is finding enough high-quality, relevant clinical evidence for your specific device. You might face gaps in the available literature or find that existing studies aren’t directly comparable. Coordinating data from various sources—like clinical trials, post-market feedback, and literature reviews—is another hurdle. Ensuring all this information is consistent, properly documented, and analyzed correctly is critical. Without a strong data quality framework, you risk having your evaluation questioned by regulators.
Aligning Stakeholders
Your clinical evaluation involves more than just your regulatory team. R&D, quality assurance, marketing, and clinical specialists all have a stake in the process. A major challenge is getting everyone aligned on the strategy’s objectives and their individual roles. Without clear and consistent communication, you can end up with conflicting priorities or last-minute changes that cause delays. It’s important to engage stakeholders early and maintain open lines of communication throughout the project. This ensures everyone is working toward the same goal: a successful and compliant submission.
Set Your Strategy Up for Long-Term Success
Developing a clinical evaluation strategy is a major milestone, but the work doesn’t stop once it’s on paper. The most successful companies treat their strategy as a dynamic guide that evolves with their product and the market. Building a framework for long-term success means creating processes that keep your strategy relevant, your team aligned, and your device compliant throughout its entire lifecycle. By embedding these practices into your operations, you move from simply meeting requirements to creating a sustainable culture of quality and safety.
Continuously Review and Update
Think of your Clinical Evaluation Report (CER) as a living document, not a one-and-done task. Regulatory bodies expect you to maintain it with fresh information, especially data from your post-market clinical follow-up (PMCF). Scheduling regular reviews—annually or whenever significant new data becomes available—is crucial. This process helps you proactively identify and address any new risks that emerge after your device hits the market, ensuring you maintain a favorable risk-benefit profile and demonstrate an ongoing commitment to patient safety.
Encourage Team Collaboration
Your clinical strategy is strongest when it’s built and maintained with input from across your organization. Silos are the enemy of effective compliance. From the very beginning, you should plan for engagement with a core group of team members from regulatory, clinical, R&D, and even marketing. When your teams collaborate, you ensure the clinical evidence you gather not only satisfies regulators but also supports your product claims and informs future device improvements. This alignment prevents last-minute surprises and creates a more cohesive approach to product development and lifecycle management.
Integrate with Your Quality System
Your clinical evaluation strategy shouldn’t be an isolated activity; it should be woven directly into your company’s Quality Management System (QMS). A strong Clinical Evaluation Plan (CEP) acts as a bridge, connecting your clinical evidence to other key quality processes like risk management (ISO 14971), design controls, and post-market surveillance. By integrating these elements, you create a closed-loop system where data from one area informs and strengthens the others. This makes compliance a systematic, repeatable part of your operations rather than a series of disconnected tasks.
Monitor Performance and Adapt
A great strategy provides direction, but it also needs to be flexible. The regulatory landscape can change, and new clinical data can shift your understanding of your device. Set clear milestones and key performance indicators (KPIs) to track your progress against your plan. Regularly monitoring your performance allows you to see what’s working and where you need to pivot. This adaptive approach helps you make smarter decisions throughout the product development lifecycle, from managing risk to planning future studies and securing device approval.
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Frequently Asked Questions
When is the right time to start developing a Clinical Evaluation Strategy? You should start developing your strategy as early as possible in the product development process. Think of it as a core part of your device’s design and development, not a final hurdle to clear before submission. Integrating it early ensures that your development goals are always aligned with your regulatory requirements, which saves you from costly redesigns and delays later on.
What’s the real difference between the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER)? The simplest way to think about it is that the Clinical Evaluation Plan (CEP) is your detailed recipe, and the Clinical Evaluation Report (CER) is the finished dish. The CEP outlines exactly what you are going to do—your objectives, the data you’ll collect, and how you’ll analyze it. The CER is the final document that presents the results of that work, summarizing the evidence and your conclusions.
Do I absolutely have to conduct a new clinical trial for my device? Not necessarily. A new clinical trial is not always required, especially for lower-risk devices or those with a long history of safe use. Your strategy might determine that a thorough review of existing scientific literature, combined with data from equivalent devices and post-market information, is sufficient to prove your device’s safety and performance. The decision depends entirely on your device’s classification, novelty, and the quality of available data.
How often do I need to update my clinical evaluation? Your clinical evaluation is a living document that must be updated throughout your device’s lifecycle. For higher-risk devices, you may need to update your Clinical Evaluation Report (CER) annually. For lower-risk devices, updates might be required every two to five years. You should also update it any time you receive significant new information from post-market surveillance that could impact the device’s risk-benefit profile.
Can I use clinical data from a competitor’s similar device? Yes, it is possible to use data from an equivalent device, but the standards for proving equivalency are very high, especially under the EU MDR. You must provide a detailed and convincing justification that the other device is truly equivalent to yours in its technical, biological, and clinical characteristics. Simply being similar is not enough; you need to build a strong, evidence-based argument for regulators.