The Market Entry of Korean Medical Devices into Germany under EU MDR Regulation = EU MDR 규제 하 한국 의료기기의 독일 시장 진입

국문 초록 (Abstract)

본 논문은 EU 의료기기 규정（MDR, Regulation （EU） 2017/745）과 독일
이행법인 MPDG 하에서 한국 의료기기 제조업체의 독일 병원 시장 진입
과정을 조사한다. MDR 이 한국 제조업체의 시장 접근 조건을 어떻게
구조화하는지, 한국 의료기기가 어떤 경로로 독일에 진입하는지, 그리고
독일 병원의 구매 관행과 전문가 인식이 한국 의료기기 채택에 어떤
영향을 미치는지를 분석한다. 정책 분석, 시장 조사, 독일 3 개 병원의
4 명의 고위 전문가를 대상으로 한 반구조화 심층 면접을 결합한
질적·탐색적 연구 설계를 채택하였다.
연구 결과, MDR 은 단순한 인증 장벽이 아닌 책임 구조를 통해 작동하는
구조적 진입 장벽으로 기능한다. 독일 병원은 독일 의료기기법에 따라
비 EU 국가로부터 직접 수입 시 제조물 책임이 병원으로 이전되므로 직접
수입을 거부한다. 병원 구매는 형식적으로 원산지 중립적이나,
실질적으로 독일어 서비스, 신속한 기술 지원, 유럽 임상 근거 등 인프라
요건에 의존한다. 한국 의료기기는 연간 3 억 3 천만~3 억 6 천만 달러의
대독 수출에도 불구하고, EU 의 경제적 운영자 구조가 제조업체 원산지
정보를 제거하여 구매 수준에서 비가시적이다. 한국 원산지가 인지되는
경우, “기술은 신뢰하나 규제 준수는 의심”하는 호의적 인식 패턴이
나타난다.
본 논문은 비가시성 역설에 대한 구조적 설명을 제시하고, 규제 구조에
의해 원산지 정보가 구매 인터페이스에서 제거되는 원산지 효과（COO）의
구조적 변형을 규명하며, 기존 학술 문헌에서 병원 수준에서 다루어지지
않았던 독일 병원에서의 한국 의료기기에 대한 수요측 실증 근거를
제공한다.
키워드: EU 의료기기 규정（MDR）, 한국 의료기기, 병원 구매, 시장 진입,
제조물 책임, 원산지 효과.

다국어 초록 (Multilingual Abstract)

This thesis investigates how Korean medical device manufacturers encounter the
German hospital market under the EU Medical Device Regulation （Regulation
（EU） 2017/745, MDR） and its German implementation through the
Medizinprodukterecht-Durchführungsgesetz （MPDG）. It asks how the MDR
structures market-access conditions for Korean manufacturers, through what
patterns Korean devices currently reach Germany, and how hospital procurement
practices and professional perceptions shape Korean device adoption. The study
employs a qualitative, exploratory design combining policy analysis, market
research, and semi-structured expert interviews with four senior procurement and
medical technology professionals at three German hospitals.
The findings show that the MDR functions not primarily as a certification barrier
but as a structural gatekeeper operating through liability architecture: German
hospitals refuse direct non-EU imports because doing so transfers full product
liability to the hospital under German medical device law. Hospital procurement
is formally origin-neutral but substantively infrastructure-dependent, requiring
German-language service, rapid-response service level agreements, and
independent European clinical evidence. Korean medical devices occupy a
paradoxical position: economically present in German trade flows （USD 330–
360 million annually） yet institutionally invisible at the procurement level,
because the EU’s economic operator architecture removes manufacturer origin
from hospital systems. Where Korean origin is recognised, perception is
favourable, yielding a “technology trusted, compliance doubted” pattern distinct
from Chinese competitors.
The thesis contributes a structurally explained account of this invisibility paradox,
extends the country-of-origin literature by identifying a variant in which origin
is removed from the buyer interface by regulatory architecture, and provides
demand-side empirical evidence on Korean medical devices in German hospital
procurement. An area that prior academic literature has not examined at the
hospital level.
Keywords: EU Medical Device Regulation （MDR）, Korean medical devices,
hospital procurement, market access, product liability, country-of-origin effect

목차 (Table of Contents)

• CHAPTER I 1
• 1. Introduction 1
• 1.1. Background and Research Topic 1
• 1.1.1. The Global Medical Device Industry and South Korea’s Position 1
• 1.1.2. The German Market and EU Medical Device Regulation 2
• 1.2. Research Questions 6
• CHAPTER II 7
• 2. Literature Review 7
• 2.1. Theme 1: EU MDR’s system-level effects and their implications for German hospitals 9
• 2.2. Theme 2: International Market Entry and hospital procurement under EU MDR (Korean manufacturers) 13
• 2.3. Theme 3: Korea as a medtech exporter and Korean devices in German hospital practice 17
• Conclusion 21
• CHAPTER III 25
• 3. Conceptual Framework 25
• 3.1. Core Concept Constructs 26
• Conclusion 31
• CHAPTER IV 33
• 4. Methodology 33
• 4.1. Research Design and approach 35
• 4.2. Data Source and sampling 37
• 4.2.1. Policy and Document Analysis 37
• 4.2.2. Market and Desk Research 41
• 4.2.3. Expert interviews (German hospitals only) 44
• 4.3. Data collection procedures 48
• 4.3.1. Policy and document analysis. 48
• 4.3.2. Market analysis 49
• 4.3.3. Expert interviews with German hospitals 50
• 4.4. Data analysis 53
• 4.5. Trustworthiness, ethics, and limitations 56
• CHAPTER V 60
• 5. Results 60
• 5.1. Theme 1: Regulatory Compliance and Liability as Structural Gatekeepers 64
• 5.1.1. Policy Analysis 65
• 5.1.2. Market Analysis 67
• Market Scale and the Notified Body Bottleneck 67
• Import Structure and the Authorised Representative Requirement in Practice 69
• MDR-Driven Market Consolidation: The Paradox of Barrier and Opportunity 70
• 5.1.3. Interview Analysis 71
• MDR Conformity as the Non-Negotiable First Filter 71
• Liability Transfer as the Ultimate Veto on Non-EU Imports 74
• MDR as Market Consolidator: Supply Gaps and Their Differentiated Impact 76
• 5.1.4. Synthesis 79
• 5.2. Theme 2: Hospital Procurement Logic: Origin-Neutral but Infrastructure-Dependent 80
• 5.2.1. Policy Analysis 81
• 5.2.2. Market Analysis 84
• The Infrastructure Model of Successful Non-EU Market Access 84
• Korean Export Profile and the Structural Invisibility Gap 85
• Hospital Financial Context and Switching Cost Dynamics 86
• 5.2.3. Interview Analysis 87
• Origin Irrelevance and the Clinical Evidence Standard 87
• Service Network and SLA as the Operational Baseline 90
• German Language and Documentation as a Hard Gatekeeping Requirement 94
• 5.2.4. Synthesis 97
• 5.3. Theme 3: Korean Medical Devices in Germany — Invisible Yet Positively Perceived 99
• 5.3.1. Policy Analysis 99
• 5.3.2. Market Analysis 101
• The Visibility Gap: Trade Flow Without Brand Presence 101
• Trade Fair Presence and the Limits of Promotional Visibility 102
• 5.3.3. Interview Analysis 103
• Structural Invisibility: Korean Origin Masked by EU Distribution 103
• Perception Where Known: Credible, Not China, Not Yet Japan 106
• 5.3.4. Synthesis 109
• 5.4. Theme 4: Conditions for Korean Market Entry — 111
• The Long-Game Model 111
• 5.4.1. Policy Analysis 111
• 5.4.2. Market Analysis 112
• 5.4.3. Interview Analysis 114
• The Required Embeddedness: What Participants Would Need to See 114
• Niche Opportunities and the Structural Challenge 117
• 5.4.4. Synthesis 119
• Conclusion 120
• CHAPTER VI 123
• 6. Discussion and Conclusion 123
• 6.1. Summary of Principal Findings 123
• 6.2. Answering the Research Questions 125
• 6.3. Situating the Findings within the Existing Literature 129
• 6.4. Evaluating the Conceptual Framework 133
• 6.5. Methodological Reflection: Effectiveness, Cost, and What a Second
• Attempt Would Change 134
• 6.6. Contributions to Knowledge 137
• 6.7. Limitations 138
• 6.8. Unresolved Questions and Their Implications 140
• 6.9. Strategic Implications and Recommendations 142
• 6.10. Directions for Future Research 145
• 6.11. Concluding Reflection 147
• REFERENCES 149
• APPENDIX A: Resources Used for the Study 156
• APPENDIX B: IRB Approval, Ethics Documentation, and Interview Questions 170