Masterarbeit

Software and Wearables as Medical Devices - Regulatory Considerations for Application in Clinical Trials ***

Lian Gelis (2020)

Summary
Language: English
During the last few years, the pharmaceutical industry has adopted digital technologies to improve the drug development process and the commercialization of new products. Technological advances are strongly supported from both the US-FDA and the EMA, but the regulatory landscape in the US seems to be more suitable to promote innovation in the digital health sector (e.g. Cures Act, PDURS). In contrast, the new Medical Device Regulation which will fully apply in 2021 sets high hurdles for medical device software to pass regulatory scrutiny.
In both regions, a digital tool must be fit-for-purpose for the intended use in the clinical trial. Irrespective of its status as a medical device, at least the basic safety and performance requirements according to local regulations should be met, quality system and surveillance requirements should be fulfilled, and the sponsor must ensure conformity with GxP and the local data privacy and cybersecurity legislations.
There is overlap in technical and clinical validation for drug development tool qualification in both regions to ensure that the digital tools deliver reliable data on tangible clinical benefits. Early engagement with the FDA and the EMA/NCAs is recommended to help define the evidentiary standards and corresponding regulatory pathway for different contexts-of-use and to clarify expectations of regulators to which extent data collected by means of digital tools are acceptable to support medicinal product market authorizations.
The outlook for the use of new software in clinical trials is hopeful, the disparate regulatory requirements in the US and EU however will make their practical implementation and inclusion in fast-moving clinical trials problematic. Drug development companies would be prudent to a) use approved solutions or b) consider software development early and in parallel to clinical development. In this way, innovative software solutions could truly introduce a new benefit in clinical trials, and not another burden in a volatile interval of drug development.
Pages: 91
Annexes: 1, Pages: 13