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References

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Regulatory Standards and Legal References

R1. European Parliament and Council. Medical Devices Directive 93/42/EEC.

R2. European Parliament and Council. Regulation (EU) 2017/745 on medical devices. Official Journal of the European Union. 2017;L117:1-175.

R3. European Parliament and Council. Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices. Official Journal of the European Union. 2023.

R4. European Parliament and Council. Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (AI Act). Official Journal of the European Union. 2024.

R5. International Electrotechnical Commission. IEC 60601-1-11. Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

R6. International Electrotechnical Commission. IEC 60601-1:2005+AMD1:2012+AMD2:2020. Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.

R7. International Electrotechnical Commission. IEC 60601-2-10:2012+AMD1:2020. Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

R8. International Organization for Standardization. ISO 10993-1:2018. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

R9. International Organization for Standardization. ISO 13485:2016. Medical devices -- Quality management systems -- Requirements for regulatory purposes.

R10. International Organization for Standardization. ISO 14971:2019. Medical devices -- Application of risk management to medical devices.

R11. Montgomery v Lanarkshire Health Board [2015] UKSC 11. United Kingdom Supreme Court.

R12. U.S. Food and Drug Administration. 21 CFR 890.5851. Powered muscle stimulator.

R13. U.S. Food and Drug Administration. 510(k) premarket notification. 21 CFR 807 Subpart E.

R14. U.S. Food and Drug Administration. De Novo Classification Request DEN240014: ARC-EX System. December 19, 2024.

R15. United Kingdom Statutory Instruments. The Medical Devices Regulations 2002 (SI 2002/618, as amended).