Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

Department of Economics Faculty of Informatics and Management University of Hradec Kralove Hradec Kralove Czech Republic

Int J Health Policy Manag. 2022 Dec 19;11(12):3159-3163. doi: 10.34172/ijhpm.2021.144. PubMed

See more in PubMed

Jaskyte Bahr K. An exploratory study of types of innovation in US foundations. Adm Sci. 2019;9(4):93. doi: 10.3390/admsci9040093. DOI

Porter ME, van der Linde C. Toward a new conception of the environment-competitiveness relationship. J Econ Perspect. 1995;9(4):97–118. doi: 10.1257/jep.9.4.97. DOI

Bonnin Roca J, O’Sullivan E. The role of regulators in mitigating uncertainty within the Valley of Death. Technovation. 2022;109:102157. doi: 10.1016/j.technovation.2020.102157. DOI

Maci J, Marešová P. Critical factors and economic methods for regulatory impact assessment in the medical device industry. Risk ManagHealthc Policy. 2022;15:71–91. doi: 10.2147/rmhp.s346928. PubMed DOI PMC

Guerra-Bretaña RM, Flórez-Rendón AL. Impact of regulations on innovation in the field of medical devices. Res Biomed Eng. 2018;34(4):356–367. doi: 10.1590/2446-4740.180054. DOI

Marešová P, Peter L, Honegr J, et al. Complexity stage model of the medical device development based on economic evaluation—MedDee. Sustainability. 2020;12(5):1755. doi: 10.3390/su12051755. DOI

Maresova P, Rezny L, Peter L, Hajek L, Lefley F. Do regulatory changes seriously affect the medical devices industry? Evidence from the Czech Republic. Front Public Health. 2021;9:666453. doi: 10.3389/fpubh.2021.666453. PubMed DOI PMC

Notified body shortage remains pressing as industry prepares for staggered IVDR rollout. MedTech Dive. https://www.medtechdive.com/news/notified-body-shortage-remains-ivdr-implementation/617113/. Accessed May 31, 2022.

What’s the wait? – Number of MDR and IVDR notified bodies remains stubbornly low. Bristows. https://www.bristows.com/news/whats-the-wait-number-of-mdr-and-ivdr-notified-bodies-remains-stubbornly-low/. Accessed May 31, 2022.

Van Laere S, Muylle KM, Cornu P. Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - A viewpoint paper. Int J Health Policy Manag. 2022;11(12):3159–3163. doi: 10.34172/ijhpm.2021.144. PubMed DOI PMC

Maresova P, Rezny L, Bauer P, Peter L. Impacts of the scheduled legislation change in Europe for medical device producers-system dynamics model of a firm. Transform Bus Econ. 2021;20(2):450–473.

Maresova P, Rezny L, Bauer P, et al. An Effectiveness and Cost-Estimation Model for Deploying Assistive Technology Solutions in Elderly Care. Res Sq [Preprint.]. January 10, 2022. 10.21203/rs.3.rs-1226225/v1. DOI

European Commission. Turning Europe into a true Innovation Union. European Commission. https://ec.europa.eu/commission/presscorner/detail/fr/MEMO_10_473. Accessed May 31, 2022.

Ganz RA. The impact of health care reform on innovation and new technology. GastrointestEndosc Clin N Am. 2012;22(1):109–120. doi: 10.1016/j.giec.2011.08.006. PubMed DOI