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Key insights on recent amendments to EU-MDR

The European Medical Device Regulation (EU-MDR) 2017/745 has brought many changes to the medical device industry and product availability. Thanks to the EU-MDR, product offerings are becoming more streamlined, addressing clinician preferences and hospital needs with quality, value and utility. Learn more about the history of the EU-MDR and its recent amendments.

Brief history of the EU-MDR

The MDR came into force on 26th May 2017 and became applicable on 26th May 2021 in all EU member states. This regulation has replaced the Medical Device Directive (MDD) and sets reinforced rules for applying the ‘CE’ mark to medical devices.

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The regulation aims to bring about significant improvements to the MDD system. The reinforced rules bring:1

  • Stricter previous control for high-risk devices with the involvement of a pool of experts at the EU level
  • The reinforcement of the criteria for designation and processes for oversight of notified bodies
  • The inclusion of aesthetic devices under the scope of the regulation
  • Improved transparency through a comprehensive EU database on medical devices and a device traceability system based on a unique device identification
  • The introduction of an ‘implant card’ for patients containing information about implanted medical devices
  • The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations
  • The strengthening of post-market surveillance requirements for manufacturers
  • Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

Why is the EU-MDR important?

The EU-MDR aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of the health of patients and users.

The regulation also sets high standards of quality and safety for medical devices to meet common safety concerns by ensuring, among other things, that the data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.

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Recent EU-MDR amendments

Though it comes with many changes, ensuring the highest quality of safety and quality in medical devices is likely to lead to clinical efficiencies, including:

  • Less training time2
  • Improved product familiarity3
  • Fewer errors4
  • More time to focus on patient care5

Since taking effect in May 2021, the EU-MDR has included regulation (EU) 2023/607, updating the transition period until the end of December 2027 for class III and class IIb implantable devices, with a few exceptions.6 For class IIb implantable devices not covered above, class IIa devices and for class I devices placed on the market in sterile condition or having a measuring function, the transition period has been updated until the end of December 2028.6

Learn more about the impact of the EU-MDR and its recent amendments:

LEARN MORE ABOUT EU-MDR

References

  1. European Commission, Medical Devices – New Regulations, Overview. Last updated 7 February 2022. Accessed 15 January 2024 at: https://health.ec.europa.eu/medical-devices-new-regulations/overview_en.
  2. Leveraging Product Standardisation for Health System Efficiency. Published 28 March 2018. Accessed 15 January 2024 at: https://mms.mckesson.com/resources/standardizing-my-products/leveraging-product-standardization.
  3. Mullins D, Persaud EJ, Ferko NC, Knight B, Tripodi D, Delatore P. SKU Optimisation Initiatives Can Create Cost Savings in an Era of Value-Based Care. Healthcare Financial Management Association. Posted January 31, 2019. https://www.hfma.org/topics/hfm/2019/february/62987.html. Accessed July 26, 2021.
  4. Leotsakos A, Zheng H, Croteau R, Loeb JM, et al. Standardisation in patient safety: the WHO High 5s project. Int J Qual Health Care. 2014;26(2):109-116.
  5. Virginia Mason Institute. Case study: Surgical setup reduction improves patient outcomes. Published 12 December 2023. Accessed 15 January 2024 at: https://www.virginiamasoninstitute.org/resource/surgical-setup-reduction-improves-patient-outcomes/.
  6. Official Journal of the European Union. REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Published 20 March 2023. Accessed 15 January 2024 at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0607.

This list of references to third-party peer-reviewed material and the sites they are hosted on are provided for your reference and convenience only, and do not imply any review or endorsement of the material or any association with their operators.  The Third-Party References (and the websites to which they link) may contain information that is inaccurate, incomplete, or outdated. Your access and use of the Third Party Sites (and any websites to which they link) is solely at your own risk. 

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