Medical Device Regulation: Should We Care About It?

Abstract

Medical devices are subject to strict regulatory and approval processes to enter the market and to be used by operators and patients. These are needed to guarantee the users’ safety. The different activities of these processes have important implications for all involved stakeholders and for the whole lifecycle of a medical device. The aim of this work is to provide an overview of some key aspects of the new EU Medical Device Regulation and to show why researchers, innovators and clinicians should care about it. Awareness of regulatory requirements can improve the innovation process and its efficiency in terms of both social and ethical impact, but this awareness needs to be raised in the upcoming months and years. One can shortly say “yes, one needs to take care” of the new EU Medical Device Regulation. First and foremost, it is crucial for the sake of the users’ safety, which is the regulation’s intrinsic goal. Second, it should not just be seen as an obstacle for new innovations in the medical domain, but as a chance as it can provide new opportunities.

"Current Perspectives on Medical Devices and the Quest for Clinical Data to Support their Marketing Authorization: A Short Overview"

“…To demonstrate that a MD meets the "essential requirements", i.e., that it is safe, that it works as intended by the manufacturer, and that any risks are acceptable when compared to the benefits of the MD, it is necessary to collect clinical data and perform a clinical evaluation. However, sometimes, a non-clinical assessment can also be used to establish the benefits of an MD: e.g., usability testing, computer modelling and simulations, and cell-based testing [8]. The clinical evaluation of this data must follow a well-defined and methodologically sound procedure based on the following key aspects: a) Critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the MD, where the following requirements are met: i.…”

Implementation of health technology: Directions for research and practice

“…Nowadays, new challenges are the validation and certifications of new and all existing health technologies under the new Medical Device Regulations (MDR) of which many aspects are still unknown (15). Careful planning is needed to van Gemert-Pijnen 10.3389/fdgth.2022.1030194…”

“…Nowadays, new challenges are the validation and certifications of new and all existing health technologies under the new Medical Device Regulations (MDR) of which many aspects are still unknown ( 15 ). Careful planning is needed to fulfil the regulatory demands for healthcare technologies, to guarantee safety, security before the technologies go to the EU-market.…”

Simulation-based research for digital health pathologies: A multi-site mixed-methods study

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