Proposal to amend the MDR and IVDR

The In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) entered into force in 2017 and has been applicable since 26 May 2022. It was adopted together with the Medical Devices Regulation (EU MDR 2017/745), which has been applicable since 26 May 2021.

However, many In Vitro Diagnostics (IVDs) currently on the market have yet to comply with the IVDR.

Hence on 23 January 2024, the European Commission published a new proposal to update the provisions of both the IVDR and MDR, and amend the legislation by:

  • Further extending the transition period for certain IVDs.
  • Requiring manufacturers to give prior notice of potential shortages of critical medical devices and IVDs.
  • Enabling a gradual roll out of the European Database on Medical Devices (EUDAMED).

It’s worth noting that this new proposal has followed on from previous proposals to amend the MDR and IVDR regarding various factors, that have since been adopted:

  • Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending the MDR and IVDR as regards the transitional provisions for certain medical devices and IVDs. The Regulation introduced a staggered extension of the transition period provided for in MDR, subject to certain conditions. It also deleted in both MDR and IVDR the “sell-off” deadline.
  • Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in the IVDR and deferred the application of conditions for in-house devices. While the IVDR has been applicable since 26 May 2022, the amendment allowed for progressive rollout regarding IVDs covered by a certificate, or a declaration of conformity issued in accordance with the In Vitro Diagnostic Directive 98/79/EC (IVDD).
  • Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending the MDR, as regards the dates of application of certain of its provisions, including the MDR entry postponement to 26 May 2021.

Transition period extension for certain IVDs

The section of the proposal relating to the extension of the transition period of certain IVDs, differentiates between risk classes and details the need to meet certain pre-requisites.

High risk IVDs will have the shortest transition period and those of lower risk have the longest transition periods.

  • High risk IVDs (Class D) – new proposed transition period to 31 December 2027
  • Medium risk IVDs (Class C) – new proposed transition period to 31 December 2028 
  • Lower risk IVDs (Class B and Class A sterile) – new proposed transition period to 31 December 2029
  • For non-sterile (Class A) devices – the date of application remains at 26 May 2022 with no transitional provisions

The Commission has also proposed the intention to delay to 26 May 2030 the application of one of the requirements in the IVDR for devices manufactured and used in health institutions (i.e. the requirement to show that there is no alternative and equivalent commercial device on the market)

Mitigating shortages of supply

The shortage of critical medical devices or IVDs can be a risk to patients or public health. Thus, the new proposal also introduces an obligation for manufacturers to give prior notice about any intention to interrupt or withdraw the supply of certain critical medical devices and IVDs.

Where manufacturers for any reason anticipate the interruption of supply of medical devices or IVDs and it is reasonably foreseeable that the interruption may result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer should notify the relevant competent authorities. Economic operators to whom they directly supply the device and, where applicable, the health institutions or healthcare professionals to whom they directly supply the device, thereof should also be notified.

The manufacturers will be required to provide information of shortage of supply at least six months before the anticipated interruption, and the information shall specify the reasons for the interruption. This will allow competent authorities and healthcare providers to have enough time to consider mitigating measures.

Gradual introduction of EUDAMED

To improve transparency and access to information, the new rules adopted in 2017 provided for the creation of EUDAMED. This database would eventually contain comprehensive data about all medical devices available in the European Union.

Initially, manufacturers were not required to register their medical devices on EUDAMED until all of its six modules had been set up. However, while three modules (actor registration; UDI and device registration; notified bodies and certificates) are already available for voluntary use, and two more (market surveillance; post-market surveillance and vigilance) are expected to become available in 2024, the final module (clinical investigation/performance study) is unlikely to be completed until 2027.

Hence, as part of the new proposal, to speed up the process of the usage of the database, manufacturers will be required under the new rules to provide information about their products via the completed EUDAMED modules. This will be a mandatory requirement and is expected to take effect from late 2025.

Why has the proposal been introduced and what are the pre-requisites?

The stringent changes introduced as part of the IVDR has led to an increased need for scientific, technical, and regulatory requirements. This has consequently led to an increase in the time required by manufacturers to fulfil the regulation. Additionally, there was a need to address the shortage of notified body capacity regarding those devices that must undergo a conformity assessment involving notified bodies for the first time under the IVDR.

This resulted in a vast number of critical IVDs currently on the market still not able to comply with the new rules. With an estimate of around 70% of clinical decisions relying on IVDs, this visibly introduces a risk to health care, as, when the current transition timelines have passed, these critical IVDs will need to be removed from the market without other replacements.

The proposal extending the transition deadline, will therefore mitigate the shortages of critical IVDs.

However, there are certain pre-requisites that need to be met in order benefit from the extended transition. Namely, the provision only applies to ‘legacy devices’, and these devices must also meet several conditions.

Legacy devices are those that are covered by a certificate or declaration of conformity issued under the IVDD. The conditions that must apply to these to benefit from the extended transition, are as follows:

  • The manufacturer must put in place a quality management system compliant with the IVDR by 26 May 2025
  • The manufacturer has issued a declaration of conformity according to IVDD before 26 May 2022 and continues to comply with the IVDD
  • The reinforced rules on vigilance and market surveillance will apply
  • The manufacturer does not introduce any significant changes during the transition period in the design or intended purpose of the devices.
  • For devices requiring an assessment by a notified body, the manufacturer must submit an application to the notified body to transfer the device to the IVDR by:
    • 26 May 2025 (class D)
    • 26 May 2026 (class C)
    • 26 May 2027 (class B and A sterile IVDs)
  • The manufacturer and the notified body sign a written agreement to proceed with conformity assessment no longer than 4 months after the dates signed

Next Steps for the proposal

On 14 February 2024, the Permanent Representatives’ Committee agreed on the text of the Commission proposal without amendments as a mandate for the Presidency to enter into negotiations with the European Parliament and published its agreement on 16 February 2024.

The final step is the European Parliament’s endorsement and subsequent publication of the adopted text in the Official Journal of the European Union. The European Parliament is expected to vote on the text of the Commission proposal without amendments as its position at first reading during a plenary session in April 2024.


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