Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.

ABSTRACT: Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future

SUBMITTER: Maresova P 

PROVIDER: S-EPMC8113379 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature