Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

"State-of-the-art" in new EU medical device regulations: a review of its development in medical device law, the interpretations from stakeholders, impacts, and possible solutions for implementation ***

Yuan Shi (Abschlußjahr: 2022)

Summary
Language: English
To begin with, this study highlights the absence of a clear definition of "state-of-the-art" in MDR and IVDR, and the need to conduct a study to address it.
Besides unclarity, inconsistency of reference to the term "state-of-the-art" is found in different language versions of MDR and IVDR. Then the definitions, explanations, and interpretations of the "state-of-the-art" have to be taken from other sources. Across guidance from international organisations to law experts in the EU/EFTA countries, the definitions, explanations, and interpretations of the "state-of-the-art" are summarised and presented.
Subsequently, key elements in the "state-of-the-art" as perceived by the author of this thesis are abstracted and analysed. This serves as a tool, presenting a non-exhaustive list of the key elements, to conduct further research on the opinions of stakeholders in terms of defining and understanding the "state-of-the-art".
In the research on stakeholders, the involvement, responsibilities, abilities, designated status, and roles in either giving or fulfilling the requirements of the "state-of-the-art" are presented.
At application level, the decision-making about "state-of-the-art" among the stakeholders is also mentioned, as the NB plays a central role. Together, publications from the designated experts by Member State and the rules of their designation are further analysed to illustrate why their opinions matter in light of the "state-of-the-art".
As followed, the study goes on into the topic of the evolvement of the "state-of-the-art" requirements in the medical device law, from the introduction of the "New Approach" directives back in 1985 to the development of "NLF" after 2008, aiming to deepen the understanding of the logic behind using the reference to the "state-of-the-art" as a legislative tool, and what potential pros and cons may be associated with it. "State-of-the-art" requirements turned out to be inbuilt very early as one of the principles of the "New Approach", and was rooted in the use of standards for compliance with the essential requirements set out in the directives, which has not become the GSPRs in the MDR and IVDR. Moreover, the "state-of-the-art" requirements in the MDR and IVDR already go beyond the GSPR.
Together with deepening the knowledge, the discussion goes a step further by introducing a specific topic about the use of standards to demonstrate the "state-of-the-art" for medical devices. Relevant opinions from a Notified Body are presented, and the discovery from previous analysis is used to discuss this topic.
There is a difference between the "state-of-the-art" requirements in MDD, AIMDD, IVDD and the MDR and IVDR, where a phenomenon of "missing" the "state-of-the-art" requirements has been discovered and further explained.
It also provides some insight into the future about what to focus on regarding the topic "state-of-the-art" in the MDR and IVDR in accordance with the discussion in previous chapters. For relevant stakeholders, a hierarchy of documents is also suggested for implementing the "state-of-the-art."
Pages: 56
Annexes: 4, Pages: 14