Position paper

Requirement for a periodic safety update report - Proposal for an IVD Regulation

In their General Approach (Art. 58c), Council proposed a brand new requirement in the field of vigilance reporting: a periodic safety update report (PSUR) will need to be completed and maintained by the manufacturer for each device or category/group of devices. This report will provide conclusions from analyses by the manufacturer of post-market surveillance data.

For Class C and D devices, the PSUR will furthermore need to be made available on EUDAMED together with an annual evaluation report performed by the notified body. For Class A and B devices, the PSUR will be made available to the notified body and competent authorities upon request.

EDMA strongly requests that Council altogether delete its proposed requirement for PSUR under the IVD Regulation. The regulatory framework for post-market activities as proposed by the Commission is sufficient; the PSUR should not be included.

All the information provided by the PSUR is already available elsewhere under other reporting and assessment mechanisms. It neither provides added value to the ability of notified bodies to track data on devices post-market nor does it contribute value to how a manufacturer will manage its vigilance and device follow-up. The impact of PSUR would be to require the systematic repetition of data at great cost to the IVD sector, which is >95% SME.

PSUR should not be required for IVDs:

1. It is redundant and bureaucratic –

  •  All the information required by this report is provided elsewhere and is available to the competent authorities and notified bodies. The post-market performance follow-up evaluation report (PMPF) covers all the information which would be required by the PSUR.
  •  The vigilance system relies on the accuracy of the data being provided. Because implementing the PSUR will lead to a systematic duplication of data being entered into the system this will also increase the risk for errors in the data provided. The PSUR is essentially a summary analysis of the PMPF – which is itself a summary analysis of post-market surveillance information. Furthermore, the notified body is required to provide its evaluation or summary analysis of the PSUR findings, resulting in an additional duplication of data.
  • Regular audits by the notified body will assess the continued functioning of the quality management system and that the device performs as intended. Changes to the technical documentation, including any product changes will also be assessed during audits. In addition, the notified body will have a complete picture of what is happening to the device post-market from the reports which are notified to EUDAMED (e.g. trend reporting, incident reports, periodic safety reports etc.)

2. It would be costly and have a disproportionate effect on the IVD sector – the IVD sector would need to bear the rolling cost and resourcing needed to maintain a controlled document such as PSUR and –for Class C and D devices – ensure its update to the electronic system and its formal evaluation by a notified body. The cost is estimated as being ~20 million euros per year to the IVD sector, which is >95% SME. An evaluation of PSUR by the notified body would be required for ~40% of IVDs (Class C and D products) The impact is also considerably greater for the IVD sector than that of the pharma sector, which has relatively fewer products, and considerably less diversity in products. Given the diversity of products, many more PSURs would be required for the IVD sector than may have been envisioned by the legislators.

This position is explained in more detail in the below document.