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R&Q Webinar_ Integrating CERs and Post-Market Surveillance



Q&A compilation

Please see answers to several questions asked during the webinar below!

  • For Class Is & Im medical devices, PMS Report or PSUR required as per EU MDR?

    For all Class I devices, a PMS Report is required.

  • What are some of the primary methods to address "State of the Art"? Can you provide more color on this?

    One of the primary methods for addressing state of the art is to identify similar devices. Literature and other publicly available information can then be searched for clinical information on these devices. This information can then be compiled and summarized to provide an understanding of the risks, benefits, safety outcomes and performance outcomes of similar devices and used for both the PSUR and CER. Information sources include registries, regulatory databases such as EUDAMED or MAUDE, clinical practice guidelines, or literature. The should also be supplemented by an indications-based literature search that focuses on meta-analyses, systematic reviews, and high-quality comparative clinical studies providing information on the medical condition and the risks, benefits, and outcomes of other treatment alternatives to the subject device.

  • When is a PSUR vs PMS Report required? or is one a part of the other?

    A PMS Report is required for Class I devices, while a PSUR is required for Class II and III devices.

  • How do you link the GSPRs to the hazard analysis?

    In the CER, it is required to identify which of the GSPRs are being addressed by the document.  BSI wrote a whitepaper and guide mapping the MDD ERs to the MDR GSPRs. According to the whitepaper, the following would be applicable to the CER: Requirement on Safety and Acceptable Benefit Risk Profile (MDD ER1/SPR 1 and 5), Requirement on Performance (MDD ER3/SPR 1), and Requirement on Acceptability of Side-Effects (MDD ER6/SPR 8). The clinical risks identified in the CER are compared against the risks in the hazard analyses and updates are made to hazard analysis as appropriate. The GSPRs related to risks management are also discussed in the BSI whitepaper. Risk management is tied to several other GSPRs, such as SPRs 2, 3, and 4, and the hazard analysis is part of the risk management system. We’d refer you to the following guidance which explains the applicable GSPRs in more detail.

  • What if the sales/usage data does not reveal any threat to survivorship of the device? How is a neutral data to be represented in the PMS/CER framework?

    Neutral data can simply be presented as such. There is no requirement that only favorable data be provided and in fact the MDR requires that both favorable and unfavorable data be presented. If the data indicates that there are no threats or changes, this could be used to confirm that there have been no negative changes to the risk/benefit profile of the device. This would help to confirm that the device remains acceptable and that no changes are required.

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