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<p>The release of the European Union Medical Device Regulations (EU MDR) has introduced many complexities for medical device manufacturers and has had implications for their global markets; one such complexity was the unforeseen consequence of the impact which the MDR has imposed on country registrations held outside the European jurisdiction, as certain countries abridge the Conformité Européene (CE) mark for market authorization purposes. This study focuses on the global implications for medical device manufacturers regarding the implementation of the MDR. It discusses whether the amending regulations will influence positive change regarding the MDR transition or introduce any unintended consequences. A regulatory assessment of a large enterprise medical device manufacturer’s global markets was conducted to assess the impact of the MDR on its globally commercialized products. A subsequent qualitative study was carried out with 15 other European based Medtech organizations to benchmark their understanding of the MDR effects on their global products and ascertain what actions, if any, needed to be taken prior to MDR certification. The MDRs has affected the availability of European-manufactured devices globally and has led to increased administration and workload in maintaining product registrations. While only 15 organizations were interviewed, the challenges identified were representative of the EU Medtech community and the global regulatory landscape in which these organizations operated at a point in time pre the amending regulations. This study can help develop key recommendations for manufacturers to consider in their certifications transition to MDR, as well as educating policymakers on the impact of the MDR on the global market and aiding in a lessons learned review by the EU of how the regulations were scoped and deployed in terms of effects on the manufacturers. Understanding the effect and implications of the EU MDRs on global markets will assist in the generation of an appropriate help develop global regulatory strategies, which in turn to ensure that there is no shortage of critical and life-saving devices across all markets. This study is the first of its kind to capture the effects of MDR on European medical device manufacturers’ globally commercialized products and product portfolios, detailing its effects at a point in time. The study has implications for theory and practice: academics can leverage it to understand the MDR from Manufacturing, Supply Chain, and Marketing viewpoints, and European policymakers can use it to take further action and study lessons learned.</p>

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Global market and supply chain implications of the European Union medical device regulation 2017/745 as amended by 2023/607

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月26日

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  • Thelma Marley,
  • Deirdre Barrow,
  • Olivia McDermott

摘要

The release of the European Union Medical Device Regulations (EU MDR) has introduced many complexities for medical device manufacturers and has had implications for their global markets; one such complexity was the unforeseen consequence of the impact which the MDR has imposed on country registrations held outside the European jurisdiction, as certain countries abridge the Conformité Européene (CE) mark for market authorization purposes. This study focuses on the global implications for medical device manufacturers regarding the implementation of the MDR. It discusses whether the amending regulations will influence positive change regarding the MDR transition or introduce any unintended consequences. A regulatory assessment of a large enterprise medical device manufacturer’s global markets was conducted to assess the impact of the MDR on its globally commercialized products. A subsequent qualitative study was carried out with 15 other European based Medtech organizations to benchmark their understanding of the MDR effects on their global products and ascertain what actions, if any, needed to be taken prior to MDR certification. The MDRs has affected the availability of European-manufactured devices globally and has led to increased administration and workload in maintaining product registrations. While only 15 organizations were interviewed, the challenges identified were representative of the EU Medtech community and the global regulatory landscape in which these organizations operated at a point in time pre the amending regulations. This study can help develop key recommendations for manufacturers to consider in their certifications transition to MDR, as well as educating policymakers on the impact of the MDR on the global market and aiding in a lessons learned review by the EU of how the regulations were scoped and deployed in terms of effects on the manufacturers. Understanding the effect and implications of the EU MDRs on global markets will assist in the generation of an appropriate help develop global regulatory strategies, which in turn to ensure that there is no shortage of critical and life-saving devices across all markets. This study is the first of its kind to capture the effects of MDR on European medical device manufacturers’ globally commercialized products and product portfolios, detailing its effects at a point in time. The study has implications for theory and practice: academics can leverage it to understand the MDR from Manufacturing, Supply Chain, and Marketing viewpoints, and European policymakers can use it to take further action and study lessons learned.