May 24, 2022

European regulators just updated the harmonized standards list for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) days ahead of its implementation date on May 26, 2022.

When the European Commission added the international risk management standard EN ISO 14971:2019 to its reference list, it brought the total to 10 harmonized standards that the Commission has recognized which can be referenced by test makers to satisfy conformity requirements. The EC published the news in the Official Journal of the European Union.

In addition to recognizing the risk management standard, the EC also revised the entry for the quality management systems standard ISO 13485 to correct the European forward and informative annexes, which serve as an amendment to, but do not affect the standard itself.

The other nine standards of the IVDR previously recognized by the European regulators relate to aseptic processing metrological traceability, quality management systems, sterilization and the use of symbols.

What should IVD manufacturers know about this latest addition to IVDR standards?

The EC based its decision to implement the revised harmonized standard EN ISO 14971:2019 “to take into account the latest technical and scientific progress and to adapt it to the requirements of Regulation (EU) 2017/746” (the IVDR).

As we have reported previously, the Commission has been updating the risk management aspects of the IVDR, in part, to avoid major IVD supply disruptions and avoid shortages of critical medical supplies in the European market.

More focus on risk management efforts included in IVDR

Last autumn the European Commissioners targeted essential actions for IVDR implementation that included contingency planning and monitoring in order to avoid device shortages during public health crises.  At that time, the EC also identified high-priority actions to support IDVR implementation which were described by regulators as “not essential to allow manufacturers to place devices on the market, but which would greatly facilitate the work of the involved actors.” Standards referred to by the IVDR were listed among those high-priority actions.

Earlier this year, we reported that the updated Joint Implementation Plan for the IVDR states more clearly than its previous version in 2021 the need for risk mitigation efforts in order to avoid major IVD disruptions in the European market. Under the updated plan, the European Commission elevated these discussions to the level of the Medical Device Coordination Group (MDCG), who identified a course of action which included identifying solutions for risk mitigation, such as reprioritization of work/action item, reallocation of resources and emergency guidance.

Emergo by UL will provide additional IVDR updates from EU regulators as they become available.

Learn more about EU IVDR from Emergo by UL:

  • EU IVDR 2017/746 Gap Assessment and CE Transition Support for Medical Device Manufacturers
  • In Vitro Diagnostics Regulation (EU IVDR) Training
  • Usability engineering (UE) support for the EU transition to IVDR service
  • Performance Evaluation – When, What and How to Prepare for EU IVDR webinar
  • How ISO 13485:2016 Impacts Medical Device Companies risk management whitepaper

 

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  • Kathryn Burke's picture
    Kathryn Burke

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