"Look, we just need to check the box for the notified body. Can't you just draft a clinical evaluation based on what we already have? Here’s the template; the clinical evaluation should be straightforward now, right?"
If you have asked this question, you are not alone. It is one of the most common misconceptions we encounter from medical device innovators pursuing CE mark approval or maintenance. The costly reality? Treating clinical evaluation as "just another document" can derail your timeline, inflate your costs, and potentially sink your approval altogether.
Successful device companies understand this paradigm: your clinical evaluation is not a document. It shall be deployed as a gradual strategic process.
By: Fiona Peris Sampedro, PhD with Julianne Bobela, PhD, contributing.
Having Clinical Evaluation Plan and Report templates is like having a pizza recipe: it does not guarantee you'll create a capolavoro.
Think about it: you can follow the same recipe as a master pizzaiolo, but if your ingredients are subpar (stale flour, bland tomatoes, cheap cheese), your result will be disappointing. Your clinical evaluation is the pizza. Everything else in your technical documentation provides the ingredients.
If your risk management is incomplete, your state-of-the-art assessment rushed, or your clinical investigations poorly designed, or, your clinical evaluation will reflect these shortcomings. And unlike a mediocre pizza, a weak clinical evaluation cannot simply be reordered: it requires unwinding significant development work.
The reality: clinical evaluation is not about proving your device works. It is about defining what "working" means clinically before you build.
The Template Trap: Company A thought “We can't engage in the clinical evaluation until we know our device specs." They spent 18 months developing a cardiac monitor, then discovered their 97% accuracy missed the 99.5% clinical standard. Complete redesign, back to square one.
The Process Approach: Company B thought, “We can't finalize device specs until we know what clinical performance we need." They started the clinical evaluation process early: they did a literature review in month one, identified the 99.5% requirement, and targeted 99.7% from scratch. First-time approval.
The difference? Company B asked, "What does clinical success look like?" while Company A asked, "How do we prove our device works?"
Many MedTech companies treat clinical evaluation as a compliance hurdle. The winners use it as their competitive intelligence system.
Element 1: Start with Strategic Intent, Not Compliance Boxes
Clinical evaluation creates a powerful bidirectional relationship that many companies miss. Yes, it summarizes and appraises all information from your technical file, but it also feeds back into your broader development process. When your clinical evaluation reveals risks not captured in your risk management documentation, you must loop back and update those systems.
This feedback loop means clinical evaluation is not isolated paperwork. It is integrated intelligence that drives your entire quality management system (QMS). It requires an experienced evaluator (the only technical document requiring a CV attachment) because the strategic decisions made here ripple throughout your entire development pathway.
Element 2: Early State-of-the-Art Assessment is Non-Negotiable
The most expensive mistake innovators make? Waiting until late-stage development to begin clinical evaluation work. A delayed state-of-the-art assessment can invalidate months of clinical work and force additional investment when regulatory gaps are discovered late.
Your state-of-the-art assessment should be among your earliest development activities because it:
Companies that delay this work often discover (too late) that their clinical investigations "cannot be used because they are built on endpoints that cannot be compared to the state-of-the-art benchmark devices." The cost of retrofitting is always higher than building it right from the start.
Element 3: Embrace the Living Document Reality
Your clinical evaluation work does not end with CE mark approval. Depending on your device's risk classification, you will need updates every 1-5 years. Post-market clinical follow-up, incident or vigilance data, and evolving state-of-the-art all feed into ongoing clinical evaluation updates.
This is not bureaucratic maintenance. It is how you demonstrate continued positive benefit-risk ratio versus the state-of-the-art throughout your device's lifecycle. Companies that master this process maintain compliance and build systematic intelligence about their competitive position that informs future development cycles.
Many manufacturers still operate with MDD thinking, but MDR demands quantitative analysis where qualitative assessments once sufficed. If your internal approach has not evolved past "this worked for MDD," you are heading for regulatory roadblocks.
Some warning signs of outdated thinking:
The upcoming ISO 18969 standards for clinical evaluations will not provide simple templates. Early insights suggest emphasis on process rigor, reinforcing everything discussed here. The industry trend is clear: successful clinical evaluation depends on understanding it as a comprehensive process, not documentation shortcuts.
Outstanding clinical evaluation, like outstanding pizza, requires excellent ingredients and masterful process. Compromise either, and you will get results that satisfy no one; not regulators, not patients, not your business objectives.
Companies achieving consistent regulatory success understand that clinical evaluation is strategic process work that begins early, integrates deeply with development activities, and continues throughout the device lifecycle.
Do not let clinical evaluation become your regulatory bottleneck. Our regulatory experts have guided hundreds of medical device companies past the common pitfalls that derail CE mark timelines. Let's ensure your process delivers competitive advantage, not just compliance.
Dr. Julianne Bobela is a Life Scientist with more than ten years of professional experience in the field of translational research applied to Neuroscience and more than five years of experience in Clinical, Regulatory and Quality Affairs related to Medical Devices and IVDs. Her expertise includes conducting clinical evaluations for medical devices and performance evaluation for IVDs, and preparing technical documentation and strategic planning for regulatory pathways. She is also an active member of the Veranex clinical team, supporting the setup, management and final analysis of clinical studies on medical devices. Julianne is fluent in French, German and English.