On Medical Device Software CE Compliance and Conformity Assessment

Abstract

Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no difference between the physical device, embedded software running inside a physical device. or software that constitutes the device in itself. As a result, standalone software with intended medical use is considered to be a medical device. Consequently, its development must meet the same requirements as the physical medical device manufacturing. This practice creates a unique challenge for organizations developing medical software. In this paper, we pinpoint a number of regulatory requirement mismatches between physical medical devices and standalone medical device software. The view is based on experiences from industry, from the development of all-software medical devices as well as from defining the manufacturing process so that it meets the regulatory requirements.Index Terms-Medical device software, medical software development, medical device standards, regulatory requirements, regulatory compliance• Union harmonized legislation (incl. essential requirements),• National legislation,• Harmonized standards,• Guidelines. EU harmonized legislation includes legal acts of directives and regulations. There is a significant difference between the two: regulations will enter into force directly in all member states, whereas directives define a specific set of objectives that member states must fulfill, for example, with national

Critical failure factors for continuous improvement methodologies in the Irish MedTech industry

“…Regulatory hurdles are a well-recognised bottleneck in time and cost for MD manufacturers (Bayon et al, 2016). The availability of regulatory authorities personnel and notified body (NB) services and resources can also be seen as a critical bottleneck in order to ensure that continuous maintenance activities can be performed in a timely manner and that submissions can be reviewedbut this service level is not often available (Granlund et al, 2020).…”

“…CI has been used very widely in various organisations; however, its application in respect to regulated industries has not been studied to date in any great depth (Brown et al, 2008;Moore, 2016). Studies on CI in MedTech have acknowledged and discussed that the regulatory nature of the industry can be an obstacle to CI (Nicholas, 2019;Moore, 2016;Brown et al, 2008;Byrne et al, 2021;Bayon et al, 2016;Granlund et al, 2020). Furthermore, although organisations have widely implemented CI, sustaining the momentum of CI activities have been a challenge (Mauri et al, 2010;Zollo and Winter, 2002).…”

“…The two biggest MD markets in the world are the USA at 43% and the EU at 27%, making up 70% of the world market for medical (Medtech Europe, 2021). The manufacturing of MDs is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a MD is being marketed for use (Granlund et al, 2020). The MD industry is one of the most regulated industries by laws that govern the safety and performance of devices across their lifetime, pre-and post-market lifecycle.…”

Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

“…However, this raises the question of the ML system's autonomous operation in relation to the safety and clinical performance in the medical device domain. As a result, the regulatory authorities have traditionally promoted the approach of "locked" algorithms [8,29], where the system is designed, so that it is being trained during the development phase, and the ability to improve is disabled in real-world use. The study by Feng et al investigated the problem of "locked" algorithms in the regulated medical space and proposed different policies for regulating modifications to AI/ML-based medical software systems [30].…”

A Review of Lean Adoption in the Irish MedTech Industry

“…Aside from the fact that Lean systems (LS) did not originate within the MedTech industry, this sector operates under a very stringent regulatory regime to ensure that its products are safe to use on their customers, many of whom are based in healthcare settings [16]. Globally regulatory bodies such as the European Medicine Agency (EMA) and the US Food and Drug Administration (FDA) amongst studies place stringent requirements on MedTech companies to ensure product safety in the design, manufacture, and use of medical devices.…”