MDR: MDCG issues guidance on PSUR postmarket surveillance reports

The European Commission’s Medical Device Coordination Group (MDCG) has laid out a framework for how Periodic Safety Update Reports (PSUR) can be filed by medtech companies to comply with Article 86 of the Medical Device Regulation. The postmarket surveillance reports are intended to keep regulators abreast of a product’s safety profile during its lifecycle.
 
The PSUR requirement in the MDR was included to ensure regulators can detect potential safety signals in the postmarket setting. MDCG published a guidance on how to submit and maintain PSURs on 16 December that aims to be a postmarket surveillance (PMS) system for class IIa, class IIb and class III devices that is consistent, standardized and allows for systematic reviews under the MDR.
 
MDCG also notes that multiple factors come into play when determining the granularity of data that needs to be included in the PSUR files. The group says that includes the type of device in the reports, the timespan it has been on the market, and the postmarket experience of the devices.
 
“The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR,” said MDCG. “However, manufacturers should have reasonable time to adapt their quality management systems and sufficient flexibility when they draw up and update a PSUR as long as they can demonstrate that it is in line with Article 86 MDR.”
 
PSURs already drawn up or in the process of being prepared when this guidance is published should not be expected to have followed this guidance, if those PSURs comply with the legal requirements laid down in Article 86 MDR,” the group said.
 
The reports summarize the results and postmarket surveillance data analyses of a device or group of devices that then can be used to report on any changes in the risk-benefit profile of the product and consider any future changes to the product’s status. But manufacturers can’t just be reactive about submitting the data in their postmarket data collection and instead also need to be proactive about gathering and analyzing the data as well as letting regulators know if they discover anything concerning according to MDCG.
 
“When there is evidence of an adverse change to the benefit-risk profile of the medical device(s), this information should be evaluated and considered in line with the clinical evaluation and Risk Management,” the group said. “In the event of such circumstances, there should be clear consideration and evaluation as to whether the medical device remains safe and effective.”
 
“In line with the objectives of the MDR, the PSUR should provide transparency of all Post Market Surveillance data to the Notified Body involved in the conformity assessment of the device and to the Competent Authorities,” MDCG added. “The PSUR should summarize the results and conclusions of the analysis of the data that the manufacturer has systematically and actively gathered in post-market surveillance with its device(s) and, where relevant, with similar devices.”
 
While PSURs are not required for class I devices, class I legacy devices or certain “old devices” for which no devices have been placed on the market from the product’s MDR date of application, they are required and need to be maintained for the lifespan of other devices on the market.
 
MDCG notes that a PSUR is no longer required to be updated when the last manufactured device of the device model has been placed on the market and the device's intended lifetime ends.
“The overall lifetime of a device (model) should include the time between the placing on the market of the last manufactured device and the end of the intended lifetime of that (individual) device,” the group said.
 
The guidance addresses a number of other key issues including details on the definitions of key terms, how to use PSURs for Corrective Action or Preventive Actions (CAPA) plans, how to group devices, and provides templates for submitting PSURs.
 
Guidance