Medical Device Regulation 2017/745: Impact, evaluation and practices for change execution

Medical Device Regulation 2017/745 (MDR) is a significant change in the regulatory framework for medical devices marketed in the European Union (EU), and globally standardised medical devices intended for international markets. This thesis examines the impact of this regulation and provides an evaluation of its practices for change execution. The thesis discusses various aspects of the regulation, including identifying an impact classification level/s to express the business impact on a firm as regulations change. Criteria for classifying the business impact on a firm and better describe and illustrate the management of a changing non-tariff barrier for medical devices in the EU and beyond. The research methods used in the thesis include a primary, secondary, and tertiary sources. The thesis also includes a case study to illustrate the application and validation of developed theories. The findings of the research suggest that the MDR has significant implications for medical device firms, including the need for a vocabulary of strategy that better reflects strategy-regulatory interaction, and theories that act as a foundation of critical discussion on strategy direction. Stakeholders identify the impact of regulation on medical devices and strategy however the language is not formalised. The contribution to knowledge is the development of a pool of theories that provoke thought and better understanding in a strategy-regulatory context with a vocabulary of strategy. This pool of knowledge can be used in practice by managers, to describe and understand a regulatory change event in the market. Theories and vocabulary deemed applicable in practice, for a medical device manufacturer managing the MDR, included, fracture regulatory event, optimal regulatory area for strategic option success, Unique Principal Point of Access (UPPA), regulatory proximal, product standardisation and localisation and profit transfer.

Name dc:type.qualificationname

Doctoral Thesis

Level dc:type.qualificationlevel

Student thesis

Year dc:date.issued

2025

Author dc:creator

• Savage, Ewan

Advisors dc:contributor.advisor

• Clark, Andre
• Thomas, Simon

Language dc:language

eng

Identifier

oai:pure.atira.dk:studenttheses/8dfc3f72-5206-4902-aa20-40ea0d5fd508

OAI identifier oai:identifier

oai:pure.atira.dk:studenttheses/8dfc3f72-5206-4902-aa20-40ea0d5fd508