Apr 22, 2022

Medical device manufacturers doing business in Europe should take note of a number of updates affecting in-vitro diagnostic (IVD) medical device regulations set to take effect in 2022.

First, the Medical Device Coordination Group (MDCG) has updated guidance regarding how manufacturers must draw up a summary of safety and clinical performance (SSCP) for implantable devices and class III devices.

Second, European Commissioners issued updates to their implementation plans for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) with new guidance on the Joint Implementation Plan for the IVDR.

Third, the technical documentation for the European Databank on Medical Devices (EUDAMED) that affects the Notified Bodies (NB) and Certificates module, as well as the Unique Device Identification/Devices module, has been updated by European regulators.

What do IVD manufacturers need to know about new SSCP guidelines?

The European Commission (EC) issued updated rules on how IVD manufacturers must prepare an SSCP for implantable and class III devices, not including custom-made or investigational devices, in the updated MDCG 2019-19 Rev. 1: Summary of Safety and Clinical Performance. The updates (which are summarized on page 2) include information on how SSCPs are linked with a device's Basic UDI-DI (an EU system that links devices to their regulatory documentation), in EUDAMED. In addition, a manufacturer reference number is now required information for an SSCP.

What new actions are included in the Joint Implementation Plan for the IVDR?

The EC updated the Joint Implementation Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) to include the following new high-priority actions to support IVDR implementation. As previously reported by Emergo by UL, the EC has identified top-priority efforts to be targeted by European Commissioners ahead of the IVDR’s May 26, 2022 date of application.

New high-priority actions include:

  • Develop guidance on appropriate surveillance according to Article 110(3) IVDR
  • Develop a template for applications/notifications of performance studies
  • Develop guidance on applying IVDR requirements to legacy devices and those placed on the market before May 26, 2022
  • Develop IVDR-specific guidance on harmonized administrative practices and alternative

According to Emergo by UL sources, while some of these high-priority actions may seem ambitious given the IVDR’s May 2022 date of application, many of these efforts have been assigned ongoing timeframes, and some have already been completed.

How is documentation for EUDAMED NBs/Certificates and UDI/Devices Modules to be updated?

Following the system update on April 4, 2022, the EC announced that the technical documentation for the EUDAMED NBs & Certificates module as well as the UDI/Devices module has been updated.

Regarding the updates to the EUDAMED NBs & Certificates module, the EC established that NBs should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates.

The updates to the UDI/Devices module introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market.

However, until EUDAMED is fully functional, these actions for both modules above are voluntary.

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

Additional European IVDR compliance resources:

  • EU IVDR 2017/746 gap assessment and CE Mark transition support
  • EU IVDR training for IVD medical device manufacturers
  • Whitepaper: Human factors engineering under the EU IVDR

Author

  • Kathryn Burke's picture
    Kathryn Burke

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