When do clinical studies or investigations become operationally essential for my innovative healthcare technology?

There are roughly 4 situations in which there is no way around a clinical trials for medical devices in Europe. Correctly, the are termed as clinical investigations when medical devices are to betested (also commonly referred to as a clinical study).

These are:

Conformity for Higher Risk Class Devices

Clinical investigations are often required to demonstrate the safety and performance of innovative medical devices for pre-market conformity assessment. Regulation (EU) 2017/745 (MDR) requires clinical investigations to be conducted for Class III devices and implantable devices, unless specific exceptions apply. These studies must be designed, authorized, conducted, recorded, and reported in accordance with Articles 62 to 80 of the MDR, ISO 14155:2020, and applicable national laws. Transitional regulations still apply (as of 12/2024). Manufacturers with an appropriate quality management system must be prepared to finance high-quality studies. Careful consideration must be given to design and safety aspects to demonstrate benefits and minimize risks for study participants.

Necessity for Lower Risk Class Devices

Clinical trials as part of clinical evaluation may also be necessary for medical devices in lower risk classes. Clinical evaluation, including evaluation and analysis of clinical data, is an essential part of technical documentation for innovative medical devices. For this purpose, manufacturers who may not yet have a quality management system will only be prepared to finance studies of good quality based on experience. Compromises are usually made when designing carefully and safety aspects are taken into account in a risk-adapted manner. However, even in this context, this means that the chance of demonstrating benefits increases with more careful design and that data can then be used for subsequent sales.

Reimbursement Considerations

Although not directly required by regulation, clinical investigations may be necessary to make a product reimbursable by statutory, national, or private health insurance companies. Evidence of clinical benefits and cost-effectiveness is often crucial for reimbursement decisions. For manufacturers with innovative health technologies, especially in the digital sector, authorities and health insurance companies may set high hurdles and require high scientific standards. Currently (as of 12/2024), some requirements are as stringent as those for pharmaceutical studies. As requirements frequently change, close monitoring of national and European authorities and sharing of experiences among experts is necessary. Manufacturers are often required to have a quality management system, particularly for digital applications. High-quality scientific studies must be financed with careful attention to design and safety aspects to demonstrate benefits effectively.

Marketing/Post-Market Studies

Some clinical studies are used to prove the clinical benefits of a product in real-world settings. Post-market clinical follow-up (PMCF) studies can be conducted to demonstrate long-term effects, suitability, added value, or continued safety. In conservative and patient-oriented professional circles, this necessity is often underestimated, especially for lifestyle sector products. Manufacturers should recognize that even a complex and scientifically robust clinical study may convince authorities but not necessarily experts. It is important to address unmet medical needs early in development to avoid financing additional clinical trials. Where this was missed, clinically relevant questions should be addressed with an appropriate budget and risk management.

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To ensure compliance with regulatory requirements and fully utilize the potential of your innovative medical device, it is crucial to strategically plan and conduct clinical investifgations.

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For expert advice on navigating the complex landscape of clinical investigations, contact us for an initial consultation.