Europe: Complying with EU IVDR PMS Requirements

ARQon
May 6, 2022
2 min read

With the In Vitro Diagnostic Medical Device Regulation (IVDR) taking effect on 26 May 2022, around 85% of all IVDs will be required to comply with the IVDR PMS requirements. For manufacturers to continue placing their device on the EU market, they must apply with a collection of documents for the CE Marketing certification. Postmarket Surveillance (PMS) is part of the crucial documents to be submitted. This is to upkeep the safety and efficiency of the medical device before and after it is released on the European market, as stated in Chapter VII, Article 78(1) of the IVDR.

As follows are the brief overview of the IVDR PMS requirements important to IVD manufacturers.

Post-market Surveillance (PMS)

PMS refers to an extensive process that monitors and assesses the safety and performance of medical devices and IVDs. It is a continuous process that starts when the device is onboarded into the European market. The following is critical for PMS to be effective and compliant with the IVDR:

Systematic (regularity)
Active (continual without complaints)
Documentation (including detailed information of how it was done and the results)

The three points mentioned above should be carried out as part of the audit done by Notified Bodies every 12 months minimum. This audit includes an assessment of the PMS planning, data analysis, as well as the reporting. Additionally, unanticipated audits will be done at least once every 5 years.

Reference Documents With research, many will learn that Articles 78-81 and Annexes III and XIII of the In Vitro Diagnostic Regulation (2017/746) informs you on the documentation details needed for PMS, and this information is scattered. The European Commission website will give a more substantial understanding of knowledge needed, so do keep a lookout for monthly updates that will also release on IVDR PMS.

Below are some of the documents that will be useful on the EU IVDR PMS requirements.

IMDRF guidance
ISO/TR 20416:2020
ISO/TR 20916:2019
WHO PMS guidance

Important Pointers of an IVDR-Compliant PMS Program on the EU IVDR PMS requirements includes Post-market Surveillance Plan (PMSP), Post-market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-market Performance Follow-up (PMPF), Performance Evaluation Report (PER) and Clinical performance studies

Latest updates on the IVDR

As of 20 December 2021, the European Parliament and the Council approved for an early adoptive measure for progressive adaptation to the new regulation. It would officially enter into application on 26 May 2022.

Sources

The European Union In Vitro Diagnostics Regulation

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation