EU Medical Devices IVDR 2017/746: Transition Extension Update

This article outlines the European Commission’s decision, giving manufacturing companies more time to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). It also updates the initial timelines based on the IVDR class, the use of EUDAMED, and the new requirement for manufacturers to inform national authorities and the health sector if they suspect possible medical device shortages.

Previously, the deadline for all devices placed on the market had to be in conformity with the IVDR, with various transition periods ranging from May 2025 for the highest-risk devices and May 2027 for lower-risk devices. However, on 25 April 2024, the EC (European Commission) announced new rules giving more time for manufacturers of legacy devices (those with existing certification to the In Vitro Diagnostic Directive 98/79/EC) to transition to the new requirements without compromising safety and mitigate the risk of shortages.

Introduction to the IVDR

The ‘In Vitro Diagnostic Medical Devices EU 2017/746 Regulation’ (IVDR) is a regulation put into place by the European Union for in vitro diagnostic medical devices (IVD’s). The regulation gives the guidelines for placing on the market, making available on the market or putting into service in vitro diagnostic medical devices for human use and accessories for such devices in the EU. This Regulation also applies to performance studies for in vitro diagnostic medical devices and accessories conducted in the Union.

The European Parliament have since set a strengthened regulatory framework for medical devices and IVDs. The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions. This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607.

Unfortunately, the regulation for IVD’s have impacted many companies and manufacturers as they have not been able to meet the initial IVDR transition timelines. In recent industry discussions, some barriers that are affecting manufactures are said to be mainly cost. Other general barriers include:

• • Low resources as more products will now require clinical reviews
  • Supply Chains
  • Cost to retrieve data for technical files have drastically increased
  • Labelling requirements
  • Cost of post marketing research
  • Availability and resourcing of Notified Bodies

Having IVD’s available in the market is vital for patient healthcare and safety. As a result, the European Commission in January 2024 proposed extending these timelines to give companies the capacity to comply with the IVDR. In addition to the extended timelines, the European commission also wants to improve transparency in the Medical Device industry by accelerating the launch of certain features of the European Database on Medical Devices – EUDAMED.

Overview of the Amendment

The purpose of the amendment as mentioned previously, is to extend the transitional period for certain IVDs and to help improve the availability of IVDs in the EU. The new measures include:

1. 1. Extending IVDR transition timelines.
   2. Introducing a new requirement for manufacturers to inform national authorities and the health sector if they suspect a possible disruption in the supply of certain medical devices.
   3. Accepting the gradual roll-out of EUDAMED for medical devices.

The previous timelines for the IVDR transition are as follows:

1. 1. lowest risk self-certified devices (class A non-sterile): 26 May 2022
   2. lower risk devices (class B)/(class A) sterile devices : 26 May 2027.
   3. high individual and/or moderate public health risk devices (class C): 26 May 2026
   4. high individual and public health risk devices (class D): 26 May 2025

The extension of timelines is required to mitigate the risk of shortages of devices, especially high-risk IVDs, in the EU. This is important as high-risk IVD’s are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.

The amendment also addresses the gradual roll-out of EUDAMED. The purpose of EUDAMED is to enhance traceability, co-operation and transparency of medical devices in the EU.

EUDAMED consist of six modules, covering all the features specified by the Regulations:

1. 1. 1. UDI/Devices
      2. Actors
      3. Notified bodies/Certificates
      4. Post-Market Surveillance and Vigilance
      5. Market Surveillance
      6. Clinical investigations/Performance studies

The amendment removes the concept that the use of EUDAMED can only become mandatory when all its modules have been declared fully functional. Instead, the new wording of the amendment allows a gradual implementation of individual EUDAMED modules once they have been audited and declared functional.

Finally, the amendment covers a new regulation where manufacturers are required to give prior notice if they anticipate a disruption in the supply of certain IVDs or medical devices. They must provide this information 6 months in advance to competent authorities, as well as distributors and healthcare providers. This will allow them enough time to take action to guarantee patient care. The economic operators who have received the information from the manufacturer shall inform without undue delay any other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the anticipated interruption.

New IVDR Transition Timelines

The extension of deadlines for manufacturing companies is dependent on the class of IVD in question. These extensions are only applicable to ‘legacy devices’, i.e. those covered by a certificate or declaration of conformity issued under Directive 98/79/EC before 26 May 2022. The extended timelines are as follows:

1. 1. IVDs that required Notified Body involvement under Directive 98/79/EC can be placed on the market until 31 December 2027 provided that a manufacturer has an agreement in place with a Notified Body for an IVDR assessment, or, has a derogation in place from a Competent Authority of a Member State.
   2. IVDs that did not require Notified Body involvement under Directive 98/79/EC but do so now under the IVDR can be placed on the market according to the following timelines:
   3. lower risk devices (class B)/(class A) sterile devices : 31 December 2029
   4. high individual and/or moderate public health risk devices (class C): 31 December 2028
   5. high individual and public health risk devices (class D): 31 December 2027

However, the above extended timelines are subject to the following conditions:

• • the devices must continue to comply with Directive 98/79/EC.
  • the devices do not undergo significant changes in the design and intended purpose.
  • the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
  • the manufacturer has put in place a quality management system (QMS), no later than 26 May 2025
  • by a specific date (26 May 2025, 26 May 2026 or 26 May 2027, depending on the risk class), the manufacturer, or its authorised representative, has lodged a formal application for conformity assessment with a Notified Body and has an agreement in place.

Healthcare professionals, industry and competent authorities have stated during the IVDR transitional period, supplies of numerous medical devices and IVDs have reduced or were likely to be stopped. In certain instances, where alternative devices are not available, the disruption of device supplies can put patients or public health at risk. Thus, manufacturers are now required to give prior notice if they anticipate a disruption in the supply of certain IVDs or medical devices.

Lastly, the amendment aims to enable a gradual implementation of individual EUDAMED modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025.

Three Eudamed modules have been available for voluntary use: Actors since December 2020 and UDI/Devices and Notified bodies/Certificates from October 2021. Two further modules: Market Surveillance and Post-Market Surveillance and Vigilance are expected to be completed in Q2/2024. The last module Clinical investigations/Performance studies will not be completed before Q3/2026.

The use of EUDAMED will improve transparency and provide information on devices within the EU market, helping to monitor the availability of devices.

Summary

In conclusion, the EC are aware that many IVD manufacturing companies were finding it hard to meet the IVDR transition deadline, thus extending the timelines in the current amendment. The amendment also calls for a new requirement where manufacturers are to inform national authorities and the health sector if they suspect a possible disruption in the supply of certain medical devices. Lastly, they are calling for the gradual roll-out of EUDAMED for medical devices. The overall purpose of the amendment is to ensure continued patient care in instances where certain devices may be discontinued thus the deadline has been extended.

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