What It Takes to Build a Certified Active Medical Device?
Having a certified active medical device is a brilliant target to reach and if it in the end it’ll help people – it’s even better. Well, to narrow your broad imagination – before that you need to take into consideration that a medical product development is way more than just wires soldering and molding a case. Of course, every engineering project involves research and development, but in the world of MedTech startups, there are many additional challenges to face.
Financing is often the first and most critical hurdle. Without funding, even the most brilliant idea won’t take off. Then come the regulatory requirements, R&D activities, and yes – marketing & sales. For a small team just starting out, this can feel overwhelming, even like a nightmare.
That’s where Consonance bridges the gap with a design, prototyping, testing, certification, and also small-batch manufacturing so you don’t have to hire a large in-house team from scratch. Instead, you can focus on funding, strategy, and market entry, while we make sure the technology is developed and prepared for certification. We’ve supported countless startups and companies on their journey, and the devices we’ve helped bring to life are already making a difference for patients. In this article, I’ll show you our approach – the path your project could take with us to become a certified active medical device.
A Technical Feasibility Study for an Active Medical Device
Would you go somewhere far away, for a very long time, yet the destination is unknown? I’m sure you would 🙂 Were not talking about leaving your job, your car and your home to go on a backpacking trip somewhere in Australia or Brazil…
Well, this is how it’s like to begin a MedTech project without a proper technical feasibility study. It’s crucial to take the time at the very start to consider why the device is being developed, who it’s for, who will need it, how it’s gonna work, why customers would want to buy it and how it should meet regulatory requirements. It should tell, what existing solutions address the patient needs you aim to tackle?
A technical feasibility study helps verify whether the technology behind a MedTech startup can be realistically implemented. This process includes a detailed assessment of functionality, reliability, and scalability, ensuring the solution is not only innovative but also practical. Think of the technical feasibility study as a roadmap for the project which clarifies the destination.
There’s no shortcuts, so here are some important steps you should follow:
Step 1: Clarify Your Active Medical Device Classification
The first step in certifying an active medical device is to determine its risk classification. This decision defines how rigorous and complex the conformity assessment process will be, which standards will apply, and how much time and resources will be required to bring the product to market. In practice, we often see entrepreneurs focus on building a prototype first and only later check the regulatory requirements. This is a risky approach, as it can lead to costly corrections and significant project delays. A far better strategy is to define the device’s class from the outset and tailor the entire development plan accordingly.
Doctors define the problem, while engineers ask the right questions to uncover opportunities, patient needs, and the root cause. Together, they aim to define the requirements for a potential device including function, safety, maintenance and market fit. The search for solutions usually starts broadly. Different concepts are generated and discussed to determine which approach best addresses the defined problem. Market analysis is also conducted to check whether similar devices already exist.
Build on a Solid Quality and Risk Foundation
Several basic factors influence the classification:
- the intended duration of use (temporary, short-term, or long-term),
- the level of invasiveness (whether the device comes into contact with the patient’s body or is implanted),
- whether the device is active (requires an external energy source beyond the body),
- the place of use (hospital, home etc.).
When it comes to regulatory frameworks, the rules differ by market. In the European Union, according to MDR 2017/745 (Annex VIII), there are four risk classes: I, IIa, IIb, and III. Active devices are usually classified as IIa, unless they fall under additional MDR rules that place them in a higher class. In the United States, there are three risk classes. Correctly determining the classification from the start helps limit unforeseen costs, prevents the need for major redesigns at later stages, and shortens the time to market.
Step 2: Build on a Solid Quality and Risk Foundation
Once we know the risk class of your device, the next milestone is implementing a quality management system (QMS) and a risk management process. This is a core requirement of the MDR and a cornerstone of any successful certification journey. In practice, the most efficient way to do this is by following harmonized standards. While compliance with these standards isn’t legally mandatory, it’s strongly recommended because they serve as ready-made roadmaps. ISO 13485 explains how to design and maintain a QMS that satisfies MDR requirements, while ISO 14971 guides you in establishing a rigorous risk management framework.
Together, these standards don’t create extra hurdles, they simplify the path. They spell out the documentation, processes, and controls that regulators will expect to see, making certification smoother and more predictable.
Step 3: Design, Develop and Test Your Active Medical Device
The next step is: design, prototyping, and production. This phase covers the entire scope of product development. It starts with designs and visualizations created using tools such as CAD software. At this stage, a proof of concept and multiple prototype iterations are developed to achieve the desired results. Because active medical devices are complex products, this stage brings together engineers from different fields: electronics, software development, and mechanics, working collaboratively on product development.
Be prepared to make decisions about the device’s appearance, electronics, and user interface. Effective communication and repeated iterations are essential to ensure that all elements of the device integrate seamlessly. Each iteration should be tested against the requirements: does the current version meet the specifications? Is it aligned with IEC 62366 for usability engineering? Has the device been designed with user comfort and safety in mind? By validating both technical performance and user experience early on, you avoid costly redesigns and move closer to a device that is not only functional, but also intuitive and safe in real-world use.
Design, Develop and Test Your Active Medical Device
Step 4: Prove Safety and Effectiveness
An essential step in the journey is demonstrating that your active medical device is both safe and effective. For innovative technologies, this often involves clinical studies to confirm the intended performance in real-world conditions. While not every device requires a full clinical investigation, in practice most novel active devices will need one before market approval. In parallel, comprehensive safety testing is carried out. This includes electrical safety and electromagnetic compatibility (EMC) testing to ensure the device does not pose risks to users or interfere with other medical equipment. Depending on the device type, biocompatibility, software validation, and usability evaluations may also be necessary.
Step 5: Get Certified and Launch Responsibly
If you’ve reached this point, the only step remaining before commercializing your product is an audit by a notified body. The notified body will review all technical documentation, verify management systems, and assess compliance. A successful audit allows the manufacturer to place the CE mark on the medical device, which is required for commercialization. However, obligations don’t end once the device is on the market.
Under the MDR, the manufacturer must carry out post-market surveillance. This includes actively collecting and analyzing data on the device’s performance under real-world conditions. This ongoing monitoring helps ensure safety, effectiveness, and continuous improvement.
Final Thoughts
We know this journey can be challenging. It’s complex, but the stakes are high: improving patients’ quality of life and advancing healthcare. The good news is, you don’t have to do it alone.The top priority is ensuring patient safety. You want your device to be safe, reliable, and effective and we can help make that happen.
Have questions? Interested in partnering with us? We’re here to help you.
