The Complexity of Medical Device Regulations Has Increased, as Assessed through Data-Driven Techniques

Arthur Arnould,Rita Hendricusdottir,Jeroen Bergmann

doi:10.3390/prosthesis3040029

Abstract

Medical device regulations are dynamic, as they need to cover an ever changing landscape. In Europe this has led to a new set of regulations (both for Medical Devices and In Vitro Diagnostics), which replaced the old rules. This study is interested in how the complexity of these medical regulations changed over time and if additional time-based metrics can be associated with any of the complexity metrics. Complexity is defined in terms of readability of the text and it is computed using established linguistic measures, as well as Halstead complexity scores. It was shown that the regulatory complexity of new EU medical device regulations was higher than their predecessors, especially when Halstead complexity measures were considered. The complexity metrics obtained for the new regulations were subsequently associated with the time it took to consider these regulations. Only very weak Pearson’s correlation coefficients were found between the complexity scores and the obtained response times for the new regulations. This could indicate that there are issues with how complexity is perceived by those that need to apply these regulations. Taking the complexity of regulations into account can greatly help with the development of more user friendly regulations. The results from the data-driven methods that are applied in this research indicate that governments could benefit from focusing on making regulations more accessible and utilitarian. This would improve the stakeholder adherence and facilitate effective implementation. This work also highlighted the need to develop more suitable methods to analyse regulatory text to further inform the wider research community.

Highlights

The medical device industry has been home to some of the most revolutionary innovations by mankind
All these medical device companies have to engage with the medical device regulations if they want to bring their ideas to market
The first aim of this paper is to explore how the complexity of the medical device regulations has changed when the Medical Devices Directive (MDD)/In Vitro Diagnostics Directive (IVDD) was replaced with the new Medical Device Regulations (MDR)/In Vitro Diagnostic Regulations (IVDR)

Summary

Introduction

The medical device industry has been home to some of the most revolutionary innovations by mankind. Not understanding the regulations can cause misclassification and innovators might incorrectly interpret the regulations This can have a compounding effect that leads to expensive redesign and/or retesting of certain devices. Does this hamper and discourage innovation, but companies could inadvertently develop faulty or inadequate devices This raises concerns about patient safety, whilst simultaneously presenting risks to the manufacturers who have legal liabilities and face significant losses of time and money. These outcomes are undesirable for all stakeholders and so it is vital to facilitate proper understanding of the Prosthesis 2021, 3 regulations by medical device companies and innovators. The complexity of the legal text will have a direct effect on the ability of the reader to understand it

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