Paradoxical tensions embedded in EU medical device governance
| Paradoxical tension | Description | EU legal framework | How the framework manifests the tension |
|---|---|---|---|
| Protection and safety ↔ Innovation and access | The system simultaneously seeks to ensure protection of health and safety while supporting innovation and timely access. These objectives are parallel and non-hierarchical | MDR Art. 1(1); IVDR Art. 1(1); Reg. 2023/607 Recital (5); AI Act Recital (6) | Safety, public health and innovation articulated as concurrent objectives. Transitional amendments preserve market access without lowering safety requirements |
| Exploitation (standardisation) ↔ Exploration (learning and adaptation) | Regulatory work depends on stable, standardised procedures while also requiring ongoing learning and adaptation in response to technological novelty | MDR Annex I (GSPRs); MDCG guidance; AI Act Art. 9(1); AI Act Recital (65) | Fixed conformity assessment routes coexist with lifecycle-based obligations and non-binding guidance. Continuous risk management mandated without revising the core legal text |
| Transparency and traceability ↔ Confidentiality and data protection | Expanded transparency requirements support vigilance and trust, while data protection rules restrict processing and disclosure of sensitive data | MDR Art. 33 (EUDAMED); MDR Art. 109; GDPR Art. 5(1)(c); GDPR Art. 9(1) | Public databases increase information availability, while The General Data Protection Regulation (GDPR) imposes strict data minimisation limits. No mechanism for reconciling these objectives |
| Independence and impartiality ↔ Collaboration and coordination | NBs are required to maintain strict independence, while consistent regulatory outcomes depend on coordination and shared interpretation | MDR Art. 35(5); IVDR Art. 31(5); MDR Art. 57 (MDCG) | Legal requirements enforce distance from manufacturers and prohibit conflicts of interest, while parallel provisions establish coordination structures |
| Local autonomy and discretion ↔ Central control and harmonisation | Regulatory authority is decentralised to national authorities and NBs, while harmonised rules centralise control at the EU level | MDR Art. 101; MDR Art. 33; AI Act risk classification provisions | National authorities retain enforcement responsibility and discretion but operate within increasingly centralised infrastructures and oversight mechanisms |
| Paradoxical tension | Description | EU legal framework | How the framework manifests the tension |
|---|---|---|---|
| Protection and safety ↔ Innovation and access | The system simultaneously seeks to ensure protection of health and safety while supporting innovation and timely access. These objectives are parallel and non-hierarchical | MDR Art. 1(1); IVDR Art. 1(1); Reg. 2023/607 Recital (5); AI Act Recital (6) | Safety, public health and innovation articulated as concurrent objectives. Transitional amendments preserve market access without lowering safety requirements |
| Exploitation (standardisation) ↔ Exploration (learning and adaptation) | Regulatory work depends on stable, standardised procedures while also requiring ongoing learning and adaptation in response to technological novelty | MDR Annex I (GSPRs); MDCG guidance; AI Act Art. 9(1); AI Act Recital (65) | Fixed conformity assessment routes coexist with lifecycle-based obligations and non-binding guidance. Continuous risk management mandated without revising the core legal text |
| Transparency and traceability ↔ Confidentiality and data protection | Expanded transparency requirements support vigilance and trust, while data protection rules restrict processing and disclosure of sensitive data | MDR Art. 33 (EUDAMED); MDR Art. 109; GDPR Art. 5(1)(c); GDPR Art. 9(1) | Public databases increase information availability, while The General Data Protection Regulation (GDPR) imposes strict data minimisation limits. No mechanism for reconciling these objectives |
| Independence and impartiality ↔ Collaboration and coordination | NBs are required to maintain strict independence, while consistent regulatory outcomes depend on coordination and shared interpretation | MDR Art. 35(5); IVDR Art. 31(5); MDR Art. 57 (MDCG) | Legal requirements enforce distance from manufacturers and prohibit conflicts of interest, while parallel provisions establish coordination structures |
| Local autonomy and discretion ↔ Central control and harmonisation | Regulatory authority is decentralised to national authorities and NBs, while harmonised rules centralise control at the EU level | MDR Art. 101; MDR Art. 33; AI Act risk classification provisions | National authorities retain enforcement responsibility and discretion but operate within increasingly centralised infrastructures and oversight mechanisms |
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