Purpose: The primary objective of this study is the preparation of the certification of the Clynx® Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017/745 (MDR). Methods: The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certification process essential for obtaining a Conformité Européenne (CE) marking for Class IIa medical device software. This section explores the intricate aspects of the certification process, emphasizing the compilation of Technical Documentation, the nuances of Clinical Evaluation, and the establishment of a Quality Management System. The approach aligns closely with the stipulations of MDR 2017/745. Results: The study includes an industry case study featuring the Clynx® Platform, developed by Clynx® Health. Insights derived from the MDR are applied to categorize an in-development version of the software as a Class IIa medical device. The preparation of certification of this product involves the meticulous creation of Intended Use, Classification, General and Safety Performance Requirements, and Clinical Evaluation files, the presentation of an experimental protocol to validate the software’s technical performance for inclusion in the Clinical Evaluation, and a description of an Internal Audit performed on the Quality Management System. Conclusion: The certification of Class IIa medical device software necessitates the compilation of thorough Technical Documentation, including an extensive Clinical Evaluation, and the implementation of a robust Quality Management System. The certification process is conducted in collaboration with Notified Bodies, ensuring adherence to the stringent requirements set forth by the regulatory framework.

Digital physiotherapy is emerging as a promising solution to enhance patient care and improve rehabilitation outcomes. This chapter explores the available solutions in digital physiotherapy, their benefits, and limitations. Best practices in implementing digital physiotherapy are discussed, emphasizing the need for personalized approaches and patient engagement. The importance of clinical and scientific validation in assessing the efficacy and safety of digital physiotherapy interventions is also addressed. The aspects of the future of digital physiotherapy, such as gamification tools, virtual reality-based therapies, wearable devices, and artificial intelligence powered platforms can impact on rehabilitation practices. With ongoing research and innovation, digital physiotherapy may have potential to optimize physiotherapy care.

Telerehabilitation offers a transformative approach to physiotherapy, offering convenience, practicality, and sustainability. This paper presents a clinical study conducted at Unidade Local de Saúde do Oeste, in Portugal, involving 37 physiotherapy patients with chronic shoulder pain who utilized the Clynx® Platform for an average of 15.22 home-based sessions. Analysis of physiotherapist login data and patient travel data allowed for evaluation of platform usability, physiotherapist time management, and environmental impact. Patients highlighted schedule flexibility and time optimization as primary advantages, with 36.85% of sessions occurring on weekends and after hours, catering especially to busy professionals. In this study, telerehabilitation saved over 12,000 kilometres of travel and related expenses, while reducing carbon emissions by over 1.30 tons. The Clynx® Platform optimized physiotherapist-patient time management, saving approximately 45.30% of time in mild patient care, which could be redirected to more acute cases, potentially alleviating waiting lists in public hospitals. Telerehabilitation demonstrated positive impacts on usability, socioeconomic factors, and environmental indicators for both patients and healthcare professionals, driving the digitization of physiotherapy towards efficient, sustainable, and patientcentric care. This study underscores telerehabilitation as a promising avenue for the future of physiotherapy.