Reports to be prepared

Reports to be prepared

Reports to be prepared

Reports to be prepared

Periodic safety update report

Manufacturers of class IIa, IIb, and III devices, including custom-made devices, must prepare a Periodic Safety Update Report (PSUR). The requirement on preparing a PSUR concerns the following:

  • Devices in accordance with the Regulation in classes IIa, IIb and III
  • Devices in accordance with the Directive (so-called Legacy devices), that have been placed on the market after the application of the regulation has come into force on 26 May 2021 
    • According to the directive, the device class of the devices placed on the market is according to the valid certificate.

The Regulation provides for the content of the periodic safety update report, frequency of updates and the assessment by the notified bodies. The periodic safety update report on class III and IIb devices must be updated at least once every year and the report on class IIa devices when needed but at least every other year.

The periodic safety update report is one of the technical device documents for devices other than custom-made devices; for custom-made devices, it is one of the documents described in Annex XIII.

PSUR can comprise one device model (Basic UDI-DI) or various device models. If one PSUR includes various devices, the manufacturer must choose a ”leading” device on which the updating frequency of the PSUR is determined. The principle is that the “leading” device is the device in the highest risk class and if there are multiple devices in this class, the manufacturer decides on the “leading” device.

The PSUR has to be an independent document that can be analysed without background material, and its aim is to assess the device’s benefit-risk ratio.  PSUR’s information content includes incidents and corrective measures, a summary of post-market clinical data and other information sources such as customer feedback, register information, literature searches and data on comparable devices. Based on the collected data, the manufacturer estimates whether the device’s benefit-risk ratio has changed. All information described in the Annexes III and XIV of the MD regulation does not need to be reported in each PSUR. In this case the manufacturer must justify why the information has not been included in the PSUR.

The PSUR of class III devices and implantable devices in accordance with the Regulation will be imported into Eudamed when Eudamed is in operation. Currently it is estimated that Eudamed will be finished in 2024. . An exception to this are custom-made devices and devices in accordance with the Directive (so-called ”legacy devices”) whose PSUR will not be imported to Eudamed.

The PSURs imported to Eudamed are evaluated by the notified body of the device that has assessed it.  Other periodic safety reports, including class III, IIb and IIa legacy devices, are assessed during the inspections by the notified bodies in connection with the assessment of the technical documents of the device.

The date of data collection for information reported on each PSUR is the same every year. In principle, the data collection period starts from the date of issue of the certificate and depending on the device class, continues for 12 or 24 months. After the end of the data collection period, the manufacturer has to immediately prepare the report.

During the time period when Eudamed is not in operation, PSURs to be imported to Eudamed are submitted to the notified body that assessed the device in accordance with the Commission instructions. The notified body submits the PSUR and their assessment by request to the supervisory authority which in Finland is Fimea.

The instructions on PSURs will be available on the Commission website after the instructions have been finished.

 

Post-market supervision report (class I devices)

The MD Regulation requires that manufacturers of class I devices prepare a post-market supervision report (Article 85). The MD Regulation does not determine the frequency of report updates. The manufacturer has to determine when the report must be updated. 

The gathered data content is comparable to that in the PSUR and it includes proactive and reactive data gathering (MD regulation, Annex III).  At least for now there is no intention for the EU Commission to draft detailed instructions on preparing a post-market surveillance report. The PSUR instructions can be utilised in the drafting of the above-mentioned report, taking the device risk class and time on the market into account. 

The competent Authority utilises the report during inspections and potentially when processing incidents.

 

Reporting of Corrective and Preventive (CAPA) actions to Fimea

According to the medical device regulation (EU) 2017/745 article 83(4), the manufacturer shall inform the competent authority (Fimea) of the preventive or corrective (CAPA) actions if a need for such actions has been identified in the course of the post-market surveillance. These CAPA actions shall not be reported to Fimea individually but as a summary report. The summary shall be submitted on Fimeas request.

The CAPA actions of class III devices and implantable class IIa and IIb devices are reported to Fimea via Periodic safety update report (Article 86) which is submitted to Eudamed. The manufacturer of other devices shall submit a similar summary report which is submitted to Fimea upon request and which is evaluated during the inspections.

The summary of the CAPA actions shall inslucde, at least, the folowing information:

  • the type of action,
  • initiation date, 
  • scope of the CAPA, 
  • status of the action, 
  • manufacturer’s reference number,
  • CAPA description, 
  • Root cause
    • internal codes with explanation
    • IMDRF codes
    • Free text
  • effectiveness of the CAPA

If the corrective measure is related to changes in the structure or intended use of the device, consult the MDCG instruction: MDCG 2020-3.