MDR/IVDR

Navigating the Transition to MDR and IVDR Compliance

The transition to the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is crucial for medical device manufacturers and stakeholders. Understanding the timeline and requirements for compliance is essential to ensure a smooth transition and continued market access.

Key Milestones in the Transition Timeline:
  • 2017: The MDR and IVDR officially came into force, marking the beginning of a new regulatory landscape for medical devices and in vitro diagnostics.
  • 26 May 2021: The application date for MDR, requiring manufacturers to start complying with the new regulations.
  • 26 May 2022: The application date for IVDR, initiating the compliance requirements for in vitro diagnostic devices.
  • 26 May 2024: This date signifies the end of the transition period (EoT) for many MDR devices. After this date, an extended transition period starts under specific conditions, providing additional time for certain devices to achieve compliance.
  • 26 May 2026: EoT for class III custom-made implantable devices, which must meet MDR requirements by this date.
  • 31 Dec 2027: EoT for both class III and class IIb implantable devices, and separately, class D devices under IVDR.
  • 31 Dec 2028: Marks the final transition date for class IIb and class IIa devices under MDR, as well as class C devices under IVDR.
  • 31 Dec 2029: The final EoT for class B and class A sterile devices under IVDR.
MDR Transition Conditions:

To ensure compliance during transition, manufacturers must adhere to the following conditions:

  • Deadline to Lodge MDR Application: Manufacturers must submit their MDR application by 26 May 2024. At the same time, manufacturers also have to put in place a quality management system in accordance with the MDR
  • Agreement with Notified Body: An agreement must be signed with a Notified Body by 26 September 2024.
  • Compliance with Previous Directives: Manufacturers must continue to comply with the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD) until full MDR compliance is achieved.
  • No Significant Changes in Design: Devices must not undergo significant changes in design during the transition period.
  • No Unacceptable Risk: Devices must pose no unacceptable risk to health and safety.
IVDR Transition Conditions:

For IVDR compliance, the following conditions must be met:

  • Validity of IVDD Certificates: Existing IVDD certificates must be valid and not revoked.
  • No Significant Changes in Design and Intended Purpose: Devices must not undergo significant changes in design and intended purpose.
  • Timely Submission for IVDR Conformity Assessment: Applications for IVDR conformity assessment must be submitted by the relevant deadlines.
Detailed Device Classification and Transition Periods:
  • Class I Devices: Must achieve compliance by 26 May 2024.
  • Class III Custom-Made Implantable Devices: Must achieve compliance by 26 May 2026.
  • Class III and Class IIb Implantable Devices: Must achieve compliance by 31 December 2027.
  • Class IIa and IIb Devices: Final transition period ends on 31 December 2028.
  • Class D Devices: Must achieve compliance by 31 December 2027.
  • Class C Devices: Must achieve compliance by 31 December 2028.
  • Class B and Class A Sterile Devices: Final transition period ends on 31 December 2029.

Understanding these timelines and conditions is critical for manufacturers and stakeholders to ensure a seamless transition to MDR and IVDR compliance. Our consulting solutions are designed to guide you through this process, providing expert advice and support to navigate the regulatory landscape successfully. Let us help you achieve compliance and maintain market access for your medical devices and in vitro diagnostics.

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