Please see answers to several questions asked during the webinar below!
For all Class I devices, a PMS Report is required.
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.
A PMS Report is required for Class I devices, while a PSUR is required for Class II and III devices.
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. https://www.bsigroup.com/LocalFiles/es-ES/Medical%20devices/Documentos%20tecnicos/General_Safety_and_Performance.pdf
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.
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.
Not necessarily. The MDR requires that the Summary of Safety and Clinical Performance (SSCP), contain a summary of the clinical evaluation and RELEVANT information on post-market clinical follow-up. So depending on the type and duration of the PMCF being conducted on your device, the PMCF data may not be updated in every SSCP. If new data is available, this should certainly be included, but there is no requirement to force the PMCF to be updated yearly in the SSCP.
If you are asking whether you can match the update schedule for your PSUR to your update schedule for your CER, the answer is yes. And in many cases our recommendation would be to match the two schedules up as much as possible to avoid as much duplication of work as possible. If there is an overlap on the first cycle we would just recommend documenting the rationale with an explanation of how the next cycle will be aligned.
Although it can be challenging for the manufacturer it can be even more difficult for the NB assessing the documents as a package in a submission. The more aligned the information is between the documents, the easier the review will be the reviewer. A cross-functional team is often required to work through the differences and align definitions and terminology. Creating a database or glossary of terms including alternate terminology, can help align risk documentation with clinical and PMS data.
To our knowledge, there is no centralized location which captures all of the clinical registries in Europe.
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.
This is generally the case, but we would recommend talking with your notified body specifically to understand what their requirements are. The NB and Competent Authority can specify a language for the documents that support the conformity assessment.
There is no specific MDR requirement which states that the intended use and indications for use be mentioned in different sections of the IFU. Note that in Annex I EU MDR refers to the “intended purpose” rather than the “intended use” so the language is a little different than in the US.
Undesirable side effects are adverse events that occur under normal or foreseeable use conditions. For example, an allergic reaction to a device would be an undesirable side effect.
If the CER is created and is missing critical information that affects the safety of the device, then it is likely that either additional work will be done to search for data regarding that. For example, if you include devices that utilize latex but your subject device does not, you may include information that is not relevant to your device. If the CER does not adequately support the device then it is likely not to be accepted.
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 NB who will write an assessment and that assessment with the original CER will be uploaded to EUDAMED by the NB. Additionally, the NB is responsible for uploading the SSCP with a notation about whether or not it has been validated.
MDR Article 10 Section 8 requires manufacturers to keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period is at least 15 years after the last device has been placed on the market.
There are currently no publicly available PSUR or PMS report references available. Some industry trade groups have been working on templates for these documents but they have not been published to date.
All devices will require a PMCF Plan or a justification as to why PMCF is not needed for the specific device. Proactive post-market activities are required for all devices and there is some overlap with these and what is included in PMCF as defined by the EU MDR.
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.
Timelines will vary by standard.
(Information is available on the CEN and CENELEC websites under the European Legislation and mandates drop down)
A CER is required for all devices, regardless of class. However, the frequency of the reports is not specified in the regulations and we typically see a 3-5 year cycle unless triggered by new information for lower risk devices. The MDR also requires either PMCF or a justification for no PMCF to be completed for all classes. The likelihood of needed PMCF is greater for higher risk devices.
"Database data for Device" is referring to public information that can be obtained from regulatory authority databases such as the FDA, Bfarm, Swissmedic or Eudamed (when available). This information may include data on serious incidents, recalls, or other key safety information about the device or similar devices.
There are currently no publicly released templates. A PSUR template is being worked on, however there has been nothing officially released by the EU Commission. R&Q has developed several templates based on the requirements of the MDR that we utilize as a framework for our clients, however these are not publicly available.
The requirements and approach for this type of device will depend on a number of factors such as, the residual risks for the device, the expected clinical benefits, whether standards or common specifications exist for the device, and more.
Without knowing the specific device, it would be difficult to define a specific approach, but in general, if the device provides clinical benefits, clinical evidence will be required. If no clinical evidence currently exists on the device or equivalent devices and the clinical benefits cannot be justified or substantiated by testing or adherence to a standard/common specification, manufacturers will need obtain clinical evidence for their device either through clinical studies or through other data such as surveys or focus groups.
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