Clinical Documentation and Vigilance: Expert Article Series on IVDR Part 4

Part 4 of a 5-part series on the IVDR that entered into effect on May 25, 2017

The ultimate goal of the In-Vitro Diagnostics Regulation (IVDR) is to increase patient safety, transparency and traceability of In-Vitro Diagnostic (IVD) devices. To do this, the IVDR introduces the Unique Device Identification (UDI) and a European database. This database, the European Databank on Medical Devices (EUDAMED), will also facilitate the flow of communication between manufacturers and operators of medical devices, notified bodies, member states and the European Commission. The EUDAMED already exists, though currently it only contains limited data and is mainly used by regulatory authorities. In the future, it will be used to integrate different databases and information.

The “new” version of EUDAMED is still in the development phase and is not expected to be in place before 2020, at the earliest. At that time, manufacturers and suppliers of IVD devices must register their organization and devices, upload relevant documentation, apply for clinical investigations and performance studies, and upload post-market surveillance documentation.

Unique Device Identification (UDI)

One database with which EUDAMED will integrate is the UDI database. The UDI is a series of numeric and alphanumeric characters that uniquely identify a specific device on the market. It also contains information such as certificates and clinical studies. The UDI, which must be affixed to and provided together with any device, allows the device to be identified and traced through the supply chain. The UDI will be phased in over several years starting with high-risk devices.

Clinical investigations and performance studies – no more grandfathering

definition of grandfather clause

As mentioned above, EUDAMED must also be used to apply for clinical investigations and performance studies. Previously, many IVD manufacturers have used the ‘grandfather clause’ to put IVD devices on the market - either by purchasing an IVD device from another company or having a certification based solely on someone else’s data. Now, the IVDR closes the door on grandfathering (as those working with IVD devices have probably already realised). Each device must demonstrate conformity with the IVDR, including the general safety and performance requirements outlined in Annex I. No more leaning on data from other manufacturers. Companies must provide additional clinical and performance studies - not just for new IVD devices but also for those already on the market. This means that, in addition to starting over and planning and executing clinical studies, companies must update their QMS to include process descriptions, if these are not already in place.

Post-market surveillance documentation

In addition to applying for clinical investigations and performance studies through EUDAMED, the IVD manufacturers must also upload post-market surveillance documentation. IVD manufacturers will be required to report Field Safety Corrective Actions (FSCAs) and incidents through EUDAMED within 15 days of becoming aware of the event (as opposed to having 30 days under the IVDD). The shorter timeframe emphasizes the need for a strong post-market surveillance system as part of a company’s QMS – both in order to meet the requirements, and to demonstrate they are adhering to them.

The post-market surveillance system must include a post-market performance follow-up (PMPF). High risk IVD device classes must also include Periodic Safety Update Reports (PSUR) as well as other post-market studies. Overall, the post-market surveillance system must accommodate the gathering of data to continuously improve the usability, performance and safety of IVD devices, as well as detect and report trends.

Unannounced audits

As mentioned in a previous article, the Notified Bodies (NBs) are required to operate a comprehensive QMS as well. This includes a detailed procedure for the conduct of unannounced on-site audits of IVD manufacturers. Therefore, it is safe to assume that (at least) Class C and Class D IVD manufacturers should expect a post-market surveillance audit from their NB at least every 12 months.

Additional resources

More information can be found in the IVDR itself and its Annexes. Notified bodies also have online publications on their websites:

In Vitro Diagnostic Regulation, including Annexes (IVDR)

BSI Group


About this Expert Article Series

The next, and final, article in this series will summarize the changes in the IVDR and also explore potential actions for accomplishing compliance with the IVDR during the transition period.

Here is an overview of the series, including links to the earlier articles:

  • Intro to IVDR
  • IVDR Classification
  • IVDR’s impact on NBs and on Manufacturers’ QMS (This article)
  • Clinical Documentation and Vigilance
  • How to best utilize the IVDR Transition period

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