The CE Mark indicates compliance with European health, safety, and environmental standards.
But obtaining this badge isn't just a legal obligation: it's a commitment to patient safety, and it’s essential to the long-term viability of your company in the healthcare market.
I’ve previously been the CEO of three different medical device startups, which means that I have ample experience of navigating the application process. In my role as HoloCare CEO, I’m currently leading the team through the process of achieving a CE Mark for our unique medical imaging technology. And even though I knew what to expect, the journey to date has been complex, costly, time-consuming, and - at times - overwhelming!
However, I believe in learning from challenges, and in sharing those learnings as widely as possible. I’m also aware that many of my fellow startup CEOs are likely to be navigating the CE Mark application process without the benefit of experience that I have. So, with that in mind, here’s a snapshot of my personal takeaways, and a summary of the most important tips I’d like to share with the medical device community.
1: Develop a Regulatory Roadmap
At the start of our application process at HoloCare, we created a comprehensive regulatory strategy - our "roadmap" to success. In this roadmap, we outlined the necessary steps and timelines for achieving the CE Mark - for example, identifying the relevant harmonised standards. We also established a plan for documentation and quality management system (QMS) implementation. Having this roadmap has helped keep us all focused and accountable. It’s also been very satisfying to track our progress as we move towards the finish line!
2. Get to Grips with Essential CE Marking Requirements
Set off on the right foot by definitively establishing which regulatory classification your device falls into. Getting this right is essential because it determines the conformity assessment route and whether you'll need to involve a Notified Body (NB). Once you’ve done this, familiarise yourselves with the essential requirements outlined in the applicable legislation, including the Medical Devices Directive (MDD) and the Medical Devices Regulation (MDR). These were the first steps we took when we began our CE Mark journey at HoloCare, and this ensured that we secured clarity and direction from day one.
3: Engage with a Notified Body
If your medical device falls into a higher-risk category, you'll need to engage with (and pay!) a Notified Body for the conformity assessment process. This might sound like a frustrating source of extra work, expense and delay, but this is far from the reality. If you make sure to provide the Body with all the necessary information, and you communicate clearly with them throughout the process, they provide expertise and guidance that is invaluable in navigating the complexities of the assessment.
5: Conduct a Gap Analysis
Conducting a ‘gap analysis’ is an important way to identify areas where your medical device and processes may fall short of regulatory requirements. The HoloCare team’s ‘gap analysis’ involved a review of our design documentation, the conducting of additional testing and clinical evaluations, and the implementation of necessary improvements to our QMS. Once we’d taken action to address the gaps we found, we were able to ensure compliance and alignment with regulatory standards.
6: Design and Implement a Quality Management System (QMS)
Developing and implementing a robust QMS has paid dividends in the months since we built it. Our QMS covers all aspects of HoloCare’s operations, including design controls, risk management, post-market surveillance, and complaint handling. Although it took a long time to create, it’s now fantastic to have a system in place to manage the ongoing compliance, quality, and safety of our technology. Remember, your QMS should comply with relevant quality standards, such as ISO 13485.
7: Compile Technical Documentation
Preparing comprehensive Technical Files (or Design Dossiers) was a non-negotiable part of the CE Mark process for us. These documents evidence HoloCare’s compliance with the essential requirements, and support our safety and performance claims. When you’re preparing this documentation, be sure to include detailed product specifications, design plans, risk assessments, clinical data, labelling, and instructions for use. Ensuring the completeness and accuracy of your technical documentation is vital for streamlining the CE Mark process and providing evidence of conformity - don’t be tempted to cut corners here!
8: Perform Clinical Evaluation
For certain medical devices, a clinical evaluation is necessary to demonstrate safety and performance. This step involves conducting a systematic review of relevant clinical data, including clinical investigations or post-market surveillance data. It is essential to ensure compliance with the applicable clinical evaluation requirements. By meeting these requirements, you enhance the credibility and confidence in the safety and effectiveness of your medical device.
9: Compile the Declaration of Conformity
Congratulations, you’ve successfully completed your conformity assessment! Now you must remember to compile a Declaration of Conformity. This is a document that declares that a medical device meets the applicable regulatory requirements, and it includes important information such as the intended purpose, product details, and the identification number of the Notified Body involved (if applicable). The Declaration of Conformity signifies the culmination of your efforts in obtaining the CE Mark, and it was certainly a big moment for the HoloCare team.
10: Monitor and Maintain Compliance
Although it’s a huge achievement, obtaining your CE Mark is - of course - not the end of your safety responsibilities. Compliance is a continuous activity, and something that we consider every day at HoloCare. For example, we have established post-market surveillance processes, we monitor user feedback, take action to address any adverse events, and commit to keeping up with regulatory changes and obligations.
I hope these tips will prove helpful to you, as well as a reminder that you’re not alone in finding the process a real challenge. There are no shortcuts to success when it comes to obtaining the CE Mark - the process is a multifaceted task that requires meticulous planning, adherence to regulatory requirements, and effective implementation of QMS. However, eventually achieving the certification is a wonderful recognition of your hard work and commitment to high standards of safety. You’ve got this!