New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

Petra Maresova,Ondrej Krejcar,Kamil Kuca,Michael Storek,Ladislav Hajek

doi:10.3390/admsci10010016

Abstract

Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.

Highlights

The current driver of developed and developing economies is innovation (Jaskyte Bahr 2019).The area of health care and medical devices is important in relation to quality of life (Parisio et al 2020; Velenturf et al 2019; Zhang et al 2018).In general, the medical device industry includes products such as therapeutic and surgical devices, patient monitoring, and diagnostic and medical imaging devices
The production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes
The results clearly show a fundamental difference between Western and Eastern European countries, where the Czech Republic is an EU

Summary

Introduction

The medical device industry includes products such as therapeutic and surgical devices, patient monitoring, and diagnostic and medical imaging devices. It is a very heterogeneous area in terms of production and markets, spilling over into different fields of manufacturing and healthcare services (Medical Devices in the EU: A Global Leader in Safety, Availability and Innovation 2015). The production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. The development and manufacturing of medical devices have to take into account the macroeconomic framework with specific factors in terms of their production and use

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Conclusion