Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Use of digital technologies in healthcare: approvals in the borderline area between medical device and medical aid – investigation and evaluation of regulatory chances and challenges - medical software applications ***

Annette Rogge-Toehgiono (Abschlußjahr: 2023)

Summary
Language: English
Digitalization in society and internet use have increased rapidly in recent decades. This trend has not stopped at the healthcare sector either. An immensely large market for digital applications lies in the medical device sector, which is determined by mobile health (mHealth) apps, wearable devices, and software-supported medical devices. As a result of the population's life expectancy increasing in parallel with this development and the associated hugely increasing healthcare costs, medical devices that can be used by patients themselves in their home environment are also becoming more and more important. The medical sector is one of the most highly regulated within our society, as safety aspects of the use on humans and especially with regard to vulnerable patients must always be considered with the highest priority. Due to the variety of possible applications, both manufacturers and authorities are increasingly confronted with the question of how the placement on the market of these diverse technologies and their further maintenance should be managed in order to guarantee the greatest possible security of the products, both from the technical point of view and also from the data protection perspective. To take this into account, Regulation (EU) 2017/745 (MDR), which came into force on May 26, 2021 and replaced Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) in the medical device sector, is now also explicitly dedicated as a basic document to software-based applications and their requirements for classification as a medical device and the regulatory requirements that must be met mandatorily for standalone software and software in combination with conventional medical devices in order to obtain market access.
The objective of this master thesis is to critically analyze and evaluate the single steps for approval processes associated with stand-alone software as well as software-supported applications in the field of medical devices in comparison to standard medical devices after introduction of the Medical Device Regulation (EU) 2017/745 (MDR). The focus of the evaluation is set on market access and risk assessment of medical device software. In this regard, it shall be clarified from a regulatory and safety perspective, how the presence of software-based applications in the medical device sector does affect manufacturing and approval processes when considered in the light of the new Medical Device Regulation (EU) 2017/745 (MDR), and to what extend the approval processes could probably be optimized. For this purpose, the following procedure has been followed. The most important eHealth technologies are first presented in a brief overview. In order to bring software applications onto the market as medical devices, numerous legal requirements must be met even during development. To demonstrate the complexity of the regulatory landscape for digital technologies in healthcare and to provide a better overview of the topic, an identification and presentation of the most relevant documents will follow. In the main part of this thesis, the life cycle of a medical device is then examined in more detail by dividing it into the single process steps followed by an evaluation. In the concluding part, the identified critical procedures and processes are summarized and discussed in a survey before a final conclusion is drawn. It turned out that manufacturers, notified bodies and also the competent authorities are facing many problems which could lead to misinterpretations and a wrong qualification and classification of the products. The complexity of the regulatory landscape could also be problematic because many documents are interlinked and are mutually dependent and have to be updated frequently. Furthermore, not all used standards are harmonized so far and the usability of the products still has a need to develop, too, because too little attention is paid to accessibility, especially for the disabled and senior citizens.  Post market surveillance is greatly facilitated by the Eudamed database, but it is not yet fully usable because it is still not complete and mandatory. So there will still be some room for improvement in the future.
Pages: 92
Annexes: 0, Pages: 0