While we're in the midst of taking the summer off from webinars (see you in the fall!) and excitedly preparing for our CER Virtual Workshop in September, we did have our most popular and best-reviewed webinar ever in May: Integrating CERs and Post-Market Surveillance. The webinar covered how data inputs and outputs of clinical, regulatory, and post-market documentation interrelate, and must be included in a variety of plans and reports per new requirements detailed in the EU MDR. We introduced a new way to think about categorizing the abundance of information ("data packets"), which based on webinar feedback, resonated with the vast majority of those who viewed the webinar.
Unsurprisingly, we received many questions from the webinar and have published answers to a large portion of them to the webinar resources page. That page is available to those who registered for either the scheduled or on-demand webinar. If you just know you're going to be interested in the full list of Q&A – and the webinar itself if you haven't watched – you can skip this blog post and simply submit the form here. But, if you're skeptical whether or not it's worth your time, we invite you to read a sampling of the Q&A below. If you find these answers helpful, chances are you'll find the additional questions and webinar itself rewarding, too.
Q: What are some of the primary methods to address "State of the Art"? Can you provide more color on this?
A: 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.
Q: How do you link the GSPRs to the hazard analysis?
A: 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 this guidance which explains the applicable GSPRs in more detail.
Q: Do you always need a PMCF plan for Class I devices or what would be a justification to not have a PMCF plan?
A: Manufacturers are required to have a PMCF plan or a justification for why PMCF is not required. There is no general exclusion based on the class of device. The MDR does not give any specifics around when it is acceptable not conduct PMCF, so a justification for not conducting PMCF would need to be based of relevant data such as existing clinical studies/data and post market history of the device. At some point in the future, there may be common specifications issued which help define the minimum amount of data required and provide justification for not doing PMCF.
Q: What if the IFU is in a language other than English?
A: The IFU will need to be translated into an approved language for the member states in which the device is sold. However, this does not impact the PMS, PMCF or CER activities for a device. The IFU information is required for the person writing the PMS, PMCF and CER documents unless they are using the same language as the IFU. If it is only available in a foreign language and the CER will be in English our recommendation would be to translate it for reference.
Q: What documents must be submitted to EUDAMED?
A: With regards to the PMS Reports, PSURs, PMCF Reports and CERs, only the PSURs for Class III and implantable devices need to be submitted to EUDAMED. CERs for new implantable and Class III devices will be reviewed by the notified body who will write an assessment and that assessment with the original CER will be uploaded to EUDAMED by the notified body. Additionally, the notified body is responsible for uploading the SSCP with a notation about whether or not it has been validated.
Q: I see a missing element here, as the need for PMCF and the associated PMCF plan is an outcome of the clinical evaluation. In order to determine PMCF needs, the evaluators should describe residual risks and any uncertainties or unanswered questions. The evaluators should also include aspects such as rare complications, uncertainties regarding medium- and long-term performance, or safety under widespread use. While if the need for PMCF is known at the time of the CEP for the clinical development plan, that is great, but aren't the data gaps and risks that could indicate a need for PMCF be analyzed in the CER?
A: This is a great question. The CER, PMCF, and PMS requirements all appear to be a circular loop with each one updating and inputting into the next. It may help to think about this in two different ways, one for a device that is established and currently on the market and one that is not yet developed.
For a device that is on the market and may have already completed a CER, it is likely that the need for PMCF may already be known or it can be easily identified because of the known history of the device. In this case, it is reasonable to expect that the need for PMCF may be known and incorporated into the creation of a MDR compliant CEP.
However, for a device in development, it is unlikely that this information is already known and you are correct that the need for PMCF would likely be an output of the initial CER. In this case, the CEP would simply state that the need for PMCF will be determined upon completion of the clinical evaluation.
Please click below for answers to more questions like those above and to view the webinar in its entirety.