Medical Device Regulations: An Update on EU (MDR, IVDR) and UK (UKMDR) Transition Deadlines

The transition to new medical device regulations in both the European Union (EU) and the United Kingdom (UK) is an ongoing process. While the original deadlines for implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU have passed, there have been extensions and grace periods granted to help manufacturers adapt to the new requirements. Similarly, the UK has implemented grace periods for certain devices to transition to the UK Medical Devices Regulations (UKMDR)

EU (MDR and IVDR):

  • MDR:

    • May 26, 2027: All high-risk devices (Class III and IIb implantable)

    • May 26, 2028: All other devices (Class IIb non-implantable, Class IIa, and Class I)

  • IVDR:

    • May 26, 2027: Class D (high-risk) devices

    • May 26, 2028: Class C (medium-risk) devices

    • May 26, 2032: Class B and A (low-risk) devices

To benefit from the extended transition periods under the MDR and IVDR, devices must have been legally placed on the EU market before May 26, 2021 (for MDR) or May 26, 2022 (for IVDR) and certified under the MDD or IVDD.

UK (UKMDR):

  • Grace Periods (only for devices legally placed on the GB market before June 30, 2023):

    • Medical Devices:

      • Class III and IIb implantable: Until June 30, 2027

      • Grace periods for other Class IIb and Class IIa devices extend until June 30, 2026. Class I devices must comply by June 30, 2024.

    • In Vitro Diagnostic Devices:

      • Class D: Until June 30, 2025

      • Class C and B: Until June 30, 2026

      • Class A devices must comply by June 30, 2027

To qualify for the grace periods under UKMDR, devices must have been legally placed on the Great Britain (GB) market before June 30, 2023, and CE marked under the MDD, AIMDD, or IVDD.

Key Points:

  • The focus is on the devices being legally placed on the market (EU or GB) before the specified dates and having the necessary certification under the previous directives.

  • While prior registration under the directives wasn't mandatory, manufacturers are now required to register their devices under the new regulations (MDR, IVDR, UKMDR) within the specified timelines.

Additional Considerations:

  • These deadlines and grace periods are subject to change, so staying updated on the latest regulations from the EU and the MHRA is crucial.

  • Manufacturers must ensure their devices meet all relevant safety and performance standards under the new regulations.

  • Consult with regulatory experts or notified bodies for guidance on specific requirements and timelines.

By understanding the current regulatory landscape and deadlines, manufacturers can plan their transition strategies effectively and ensure continued compliance, ultimately prioritizing patient safety and maintaining market access.

Guest UserComment