Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

By Dr. Leonie Esra Eyiis
On
In Blog, News & Insights

Navigating the regulatory landscape for medical devices, in vitro diagnostics (IVDs), and digital therapeutics can feel overwhelming. Unlike pharmaceutical drugs, which follow a well-trodden clinical trial pathway (Phase I-III), medical devices often face a unique – and evolving – set of requirements.

So, why should you consider conducting a clinical trial for your device? Here are the top three reasons:

1. Meet Regulatory Requirements and Gain Market Access

Medical device regulations, especially in regions like Europe under the Medical Device Regulation (MDR) 2017/745, classify devices based on risk. Understanding where your product fits is crucial:

  • Class I (Low Risk): Bandages, non-invasive tools – no clinical data needed, self-certified.
  • Class IIa & IIb (Medium Risk): Surgical instruments, diagnostic tests – require clinical evaluations and Notified Body (NB) involvement.
  • Class III (High Risk): Pacemakers, implants – must undergo clinical trials and strict NB scrutiny.

Higher-risk devices almost always require clinical trials to demonstrate safety and efficacy before earning CE marking.

2. Validate Safety and Efficacy for Your Intended Use

Regulatory bodies don’t just care about what your device does; they care about how it interacts with patients and the level of risk it presents. Three key factors determine this:

  • Intended Use: The device’s primary function.
  • Indication for Use: Specific conditions, patient populations, or disease states it’s designed to address.
  • Mode of Action (MoA): How the device delivers its therapeutic or diagnostic effect.

For example:

  • A swallowable camera for internal GI imaging has a different risk profile compared to a mobile app tracking A1C levels-and requires different levels of clinical evidence.

3. Build Trust and Competitive Advantage

Conducting a clinical trial not only satisfies regulators but also builds credibility with healthcare providers, investors, and patients. Solid clinical evidence gives your product an edge over competitors and can open doors to partnerships, insurance reimbursement, and broader adoption.

Clinical Evidence: Types of Studies You’ll Need

Depending on your device’s classification, evidence generation may include:

  • Pilot or Feasibility Studies
  • Verification (Training Set) Studies
  • Validation Studies
  • Demonstration of Equivalence (EU-specific)
  • In Silico (Computational) Studies
  • Pivotal Trials
  • Real-World Evidence (RWE) Collection
  • Human Factors & Usability Studies
  • Post-Market Safety Monitoring

Each study plays a role in proving your product’s safety, performance, and user-friendliness.

Keywords: Clinical Trials, Medical Device Regulatory Approval, MDR Compliance, CE Marking, CRO, Clinical Evidence, Sponsor, Digital Therapeutics, IVDs, Research Operations

References

  1. European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Official Journal of the European Union. 2017;L117:1-175. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
  2. Clemens N. The New European Medical Device Regulation 2017/745: Main Changes and Challenges. Clinical Researcher. 2017;26(10):27-31. https://www.researchgate.net/publication/322525958_The_New_European_Medical_Device_Regulation_2017745_Main_Changes_and_ChallengesResearchGate
  3. Kearney A, McDermott R. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Therapeutic Innovation & Regulatory Science. 2023;57(2):123-132. https://link.springer.com/article/10.1007/s43441-023-00527-zSpringerLink+1Emerald+1
  4. Rasi G, Mugelli A. European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development. Frontiers in Drug Safety and Regulation. 2022;2:1071620. https://www.frontiersin.org/articles/10.3389/fdsfr.2022.1071620/fullFrontiers
  5. Sorenson C, Drummond M. Improving medical device regulation: the United States and Europe in perspective. Milbank Quarterly. 2014;92(1):114-150. https://doi.org/10.1111/1468-0009.12043Emerald
  6. McCulloch P, Altman DG, Campbell WB, et al. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2009;339:b2112. https://doi.org/10.1136/bmj.b2112
  7. Majety D, Holborow A, Valla M. A review of the literature on the new European Medical Device Regulations requirements for increased clinical evaluation. International Journal of Pharmaceutical and Healthcare Marketing. 2023;17(3):345-360. https://www.emerald.com/insight/content/doi/10.1108/IJPHM-07-2023-0060/full/htmlEmerald
  8. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of marketing authorization. Drug Safety. 2009;32(12):1175-1187. https://doi.org/10.2165/11316550-000000000-00000
  9. Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open. 2011;1(1):e000155. https://doi.org/10.1136/bmjopen-2011-000155
  10. van Norman GA. Drugs, devices, and the FDA: Part 2: An overview of approval processes: FDA approval of medical devices. JACC: Basic to Translational Science. 2016;1(4):277-287. https://doi.org/10.1016/j.jacbts.2016.03.009

Ready to Simplify Your Regulatory Journey?

Every device is unique-and so should be your clinical strategy. Whether you’re an emerging biotech startup or an established life sciences company, partnering with experienced clinical research experts can help you:

✅ Navigate evolving regulations
✅ Design cost-effective, tailored studies
✅ Speed up time-to-market while ensuring compliance

Contact us today to discuss how we can support your next clinical trial!