PSUR under MDR: When it’s necessary, and what are the deadlines?

As part of the efforts to establish a more consistent and systematic review of post-market surveillance data by manufacturers under the new Medical Devices Regulation (MDR) 2017/745, the regulation introduces a requirement for drawing up a Periodic Safety Update Report (PSUR).

What is the PSUR?

The PSUR summarises the results and conclusions of the analysis of the Post-market surveillance data gathered as per the Post-Market Surveillance Plan. In this sense, the PSUR is part of the technical documentation on post-market surveillance created by the manufacturer and is a separate document that can be assessed separately. The PSUR provides a practical overview of the existing post-market surveillance activities and the data collected and analysed based on the PMS Plan of the device.

The PSUR shall indicate the following:

• The conclusions of the benefit-risk determination;
• The main findings of the Post Market Clinical Follow-up (PMCF);
• The volume of sales of the device and an estimated evaluation of the size and other relevant characteristics of the population using the device, among others;

Additionally, the PSUR should take into consideration the following:

• Serious incidents and field safety corrective actions;
• Records of non-serious incidents and data on undesirable side effects;
• Information on trend reporting;
• Relevant specialist or technical literature, databases and/or registers;
• Information on feedback and complaints provided by users, distributors and importers;
• Any publicly available information on similar medical devices;

Furthermore, a PSUR can be drawn for a group or category of devices (as per Basic UDI-DI). The MDCG guidance on PSUR assists manufacturers in creating the PSUR, providing templates and a summary table of PSUR requirements.

Who needs to have a PSUR?

As set in Article 86 of the Medical Devices Regulation, the PSUR is required for the following:

• MDR compliant devices 
  • Manufacturers of Class IIa devices;
  • Manufacturers of Class IIb devices;
  • Manufacturers of Class III devices;
  • Custom-made devices;
  • Annex XVI devices Class IIa, IIb or Class III;

• Legacy devices under MDR

In accordance with Article 120(3), 1st subparagraph, MDR, all relevant requirements set out in Chapter VII of the MDR on post-market surveillance, market surveillance and vigilance apply to ‘legacy devices.

Manufacturers of ‘legacy devices’ are, therefore, subject to the requirement laid down in Article 85 or Article 86 of the MDR based on their classification in accordance with the MDD.

As a consequence, they shall draw up and update PSURs in accordance with Article 86 MDR. They need to make the PSURs available to competent authorities on request (outside EUDAMED);

Manufacturers shall make available PSURs to their notified bodies in the framework of surveillance audits (outside EUDAMED) in order to allow the notified body to verify that the approved quality system and design remain compliant with the certificate issued under the MDD or AIMDD;

• Class I legacy and MDR Compliant

Class I MDR-compliant and Class I legacy devices do not need a PSUR. However, manufacturers need to prepare a PMS Report. A possible change in their risk class under the MDR should not be taken into account during the transition period. The PMS report shall be updated when necessary and made available to the Competent Authority upon request.

Is there a deadline to generate a PSUR?

Manufacturers are required to update the PSUR throughout the lifetime of the device. Nevertheless, this requirement does not apply when the last manufactured device of the device model has been placed on the market and the intended lifetime of this device has been achieved.

On the other hand, the data collection period should start at the MDR date of application. Manufacturers are then required to either submit the PSUR to the Notified Body via EUDAMED or to make it available to the Notified Body involved in the conformity assessment.

Legacy device manufacturers do not need to submit the PSUR to EUDAMED but shall make it available – upon request – to the Competent Authorities and the Notified Body.

As stated in the MDCG Guidance, the PSUR must be available:

• For MDR devices
  • MDR certified Class III and Class IIb implantable devices: one year after device certification date;
  • MDR certified Class IIa implantable devices: two years after device certification date;
  • MDR certified Class IIb non–implantable devices: one year from the device certification date;
  • MDR certified Class IIa non–implantable devices: two years from the device certification date;
  • Custom-made devices: one year (if Class IIb and III) or two years (if Class IIa) when the first statement of conformity is issued;

• For Legacy devices
  • MDD certified Class III or IIb implantable devices: the year following the MDR date of application – By May 26, 2022;
  • MDD certified Class IIa implantable devices: the second year following the MDR date of application – by May 26,  2023;
  • MDD certified Class IIb non-implantable devices: the year following MDR date of application – by May 26, 2022;
  • MDD certified Class IIa non-implantable devices: the second year following MDR date of application – by May 26, 2023 ;

Do you have any further questions on MDR compliance requirements? Do not hesitate to contact us!