R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and in April, we joined forces to offer up a premium webcast. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, presented PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar is an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization.

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If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides). R&Q is here to help address any other questions that you may have regarding audits or any other Post-Market Surveillance related topics. Contact us today to find out how we can help! 

Q: If current devices CE marked have received extension under Medical Device Directive (MDD) until 2024, do we need to show Post-Market Surveillance (PMS) complying to Medical Device Regulation (MDR) for the next Notified Body (NB) audit?

A: Yes. MDD Certificates issued by Notified Bodies under Directives 90/385/EEC and 93/42/EEC from 25 May 2017 will remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance (up to 27 May 2024). The device must continue to be MDD compliant (no significant changes) and must meet the MDR requirements for PMS, surveillance, vigilance, and registration of economic operators and devices, following the 26 May 2021 date of applicability.

Q: What is the difference between the PMS report and PSUR and how should this be addressed in the reports?

A: PMS reports are for Class I devices and do not require sales data. These reports do not have a defined time frame for updates (“as needed”).

Periodic Safety Update Reports (PSUR) are for Class IIa, IIb, and III devices and must be maintained for the expected life of the device (e.g. capital equipment that may be in use long after commercial sales are discontinued). Class IIa medical device PSURs are to be updated when necessary and, at least, every two years. Class IIb and class III medical device PSURs are to be updated at least annually. PSURs for Class III and Implantable Medical Devices must be submitted utilizing designated electronic system (i.e. EUDAMED, once available) to the Notified Body who reviews and uploads their evaluation into the system. The PSURs and the Notified Body evaluation shall be made available to Competent Authorities via the electronic system.

Most of the requirements are the same for both reports, although you would expect more PMCF for the higher risk devices

Q: Do you know if there has been any finalization of a PSUR template?

A: There is not a standard PSUR template or template guidance right now. The development of this highly sought-after template has been delayed due to a change in who has ownership of development. Manufacturers will need to develop the structure of their PSURs to ensure they meet the reporting requirements. Although not the same information, there are clues to be found in the PMCF and SSCP template guidances. Even if you are not dealing with a high-risk device, the definitions and explanations in these guidances can be useful for drafting a PSUR. Some of the general device information would apply across all plans/reports and having a consistent format can reduce the burden of completing this section of the template.

Q: Is there a clear difference between a PMS activity and a PMCF activity?

A: Post-Market Clinical Follow-up (PMCF) is clinical data and supports both PMS and PMCF. PMS data includes reactive data as well (customer complaints, Corrective and Preventative Actions (CAPA), Field Safety Corrective Actions (FSCA)) that is not considered PMCF. If the data to be collected is proactive clinical data I would default to putting it in the PMCF plan and then referencing the PMCF plan in the PMS plan.

>> On-Demand: RQM+ Live! #6 - PMCF Process in Action: Best Practices for MDR Compliance

Q: How should the Clinical Evaluation Report (CER) be used for the PSUR? One of the deliverables of the PSUR is the possible update to CER, Risk Management, CAPA, and labeling, among others. However, should the CER be updated before the PSUR, using the same set of data from PMS data, or wait until the PSUR is completed?

A: There is no specified sequence of events in the regulation. From a best practice standpoint, our approach is to work on the documents in parallel and route them for approval at the same time. That way the raw data from PMS reactive and proactive data are in alignment with both the CER and the PSUR.

Some organizations are using board type approvals, so the respective groups are in the same meeting and agreeing on changes at the same time. To avoid duplication, you want to align your literature searches.

Q: What triggers the start of PMS activities? Is it the release of a product in our quality systems or placing a product on the market?

A: For new products, having a PMS and PMCF plan is part of EU MDR compliance, so at the time a Declaration of Conformity is signed, the plans should be in place. That signature can happen at the time the product is first distributed.

Q: If you take field action in a third world country do you need to take the same action in the European Union (EU) or just let the EU know you took or are taking the action?

A: Per Article 87, at a minimum, the relevant Competent Authorities must be notified of any third country field safety corrective action. Depending on the nature of the corrective action, the need for field action in the EU should be assessed but may not necessarily be needed.

Q: Can we incorporate multiple variants of a product family into the same PMS/PMCF Plan?

A: Yes. The PMS/PMCF plan can incorporate a group/family of devices, when applicable. Appropriate plans for gathering post-market data about your product or product-family need to be set up accordingly. You will need to justify the grouping of your plans and reports. If multiple devices are part of a system and the clinical evidence is on the system, instead of the individual device, it may make sense to group them. However, we have seen Notified Bodies push back when there are too many disparate devices in a single plan/report.

Keep in mind that in the Summary of Safety and Clinical Performance (SSCP) guidance it states that each SSCP can only have one unique basic UDI. So as long as all the different variants are assigned a single basic UDI, then it should be fine to put all the variants in a single PMS plan/report, CER, etc. It would be suggested to keep to a single basic UDI per report.

Q: What is the Notified Body expectation for validation of the layperson language in the Summary of Safety and Clinical Performance (SSCP)?

A: The SSCP Guidance, MDCG 2019-9, does not define a methodology for verification of language. Alternatively, FDA does have a Labeling Comprehension guidance document that, while written for drug products, can offer a good overview of how to assess layperson comprehension.

Q: Is a PMCF required for Class 1 medical device that is non-measurable or non-sterile?

A: PMCF plan must always be considered for all classes of devices. The PMCF plan should be part of the PMS plan. The PMCF process must be appropriate for the risk classification of the device and must support the claims of the device. The decision to conduct (or not conduct) PMCF studies/activities must be based on the identification of possible residual risks and/or unclarity on long term clinical performance that may impact the benefit/risk ratio. If no PMCF, a documented justification for not performing PMCF is required.

Q: What level of state of the art data would you expect to have to provide in Post-Market Surveillance (PMS)?

A: Annex III requires that your PMS includes an assessment of similar devices. The best-case situation is to align your PMS activities with your CER activities and leverage the State of the Art (SOTA) assessment in both places, without duplicating the effort.

Q: For a Class 1 medical device self-certified under MDD, what are the MDR regulations applicable until May 2021, except PMS, if the extension of MDR is approved?

A: All elements of the MDR, applicable for a Class 1 self-certified medical devices, have been extended to May 26, 2021. This also gives the flexibility to keep your existing Class I self-certified MDD Declaration of Conformity (DoC), issue a new MDD DoC, if needed, or even add new Class I part numbers to it up to May 26, 2021.

Q: What will be the consequences of off-label use?

A: In the context of your device use, you must assess the risk of off-label use and then take appropriate mitigating steps. If your device is used almost exclusively for off-label use, then the expectation from the Notified Body would be that you would need to test and label your product appropriately or your certification would be at risk. On the other hand, if off-label use represents a small portion of the device usage, and poses little risk to the patient, then appropriate precautions in your Instructions for Use (IFU) may be adequate.

>> On-Demand Webinar: EU MDR Audits: Preparing, Managing & Responding to Nonconformances 

Q: What should we anticipate if our current Notified Body has not yet been approved under the MDR?

A: It would be suggested to fully understand the status of your current Notified Body to determine if a contingency would be needed to switch to an approved Notified Body. Confirm that their designation includes the scope of your products. The New Approach Notified and Designated Organizations (NANDO) information database for Notified Bodies identifies the product codes that the Notified Body has received the designation for and is authorized to give certification for, under the EU MDR. Use "2017/745" in the regulation field to filter the database to locate the appropriate designated Notified Bodies.

Keep in mind that switching a Notified Body will have very long lead times and Notified Bodies are being very selective on new clients and are very stretched to capacity at this time.

Q: How to calculate threshold values of performance and safety indicators?

A: It is up to each manufacturer to determine the criteria that they will use to define thresholds. Based on sales, device usage, and expected failure rate, you would establish an expected level giving yourself some margin to establish trigger points for reporting. You should be engaging with a statistician or utilizing established statistical methods to justify your approach.

Q: How would you recommend controlling records for the PMS plan and report revisions? We have a very large portfolio that will require several plans and hundreds of reports.

A: If possible, group products appropriately (ex. by type or class) to aid in organizing the workload and then put these on a scheduled plan to handle each group by a certain time-frame (i.e. by month, by quarter, etc.). Have a program manager in place to ensure timelines are kept. This way you can concentrate on working on getting that certain product group done together and out of the way.

Each manufacturer will need to work within its own Quality Management System (QMS) to best define how to do this. The MDR states that the PMS documentation must be presented in a clear, organized, readily searchable, and unambiguous manner.

Q: When it comes to the Economic Operator communication requirement, we have good processes for complaints and field actions but not so much for non-complaint data. How do you recommend we approach the gathering of non-complaint data for PMS?

A: Some strategies for gathering this information would be requesting trip reports from when Economic Operators visit potential customers, trade show attendance, or other industry activities. Establishing regular meetings and documenting the meeting minutes can also be another form of gathering this information.

Q: What is an appropriate way to capture publicly available information about similar medical devices?

A: This is difficult to answer right now since this will be dependent on EUDAMED and how/when other manufacturers will report their information in the system. Product registries or databases are good places to get info on similar devices, although these are more prevalent to implants or orthopedics.

Additionally, you can consider your biggest competitors and their products and then do literature or database searches for those. Look at the adverse events reported for those products. Go to the competitor’s website to see if they posted any studies or articles. Review ClinicalTrials.gov to see if they have registered a study or results. You can also look into other global databases to see if they have anything. While this may not be the most solid process, it does allow you to set your protocol to identify where you are looking and the plan to gather the information. The goal is to try to understand what they are doing that you should consider or perhaps are they seeing different adverse events that you should be looking out for.

Q: Is it required to follow standard ISO 14155 for a retrospective method of PMCF?

A: It depends on whether you meet the definition of a clinical investigation. This is tied to what information you are going to extract from those records or what are you not going to extract. Look at the objectives of the study and how you are running it; how you are getting the data; what data you are going to have access to; determine whether or not that meets that definition. If you do meet the definition, then you would want to go through ISO 14155 and all the elements that are required.

Q: If PMCF is not applicable, do we need to create a PMCF plan with justification? Or can we add the justification for no PMCF in the PMS plan?

A: This would be fine to do in a PMS Plan. The PMS plan needs to encompass PMCF, so the justification does not need to be in a separate document. The justification does need to be strong and sound to explain why PMCF is not needed.

Q: What is the difference between Post Market Surveillance and Market Surveillance?

A: Market Surveillance (Article 93) activities are carried out by the Competent Authorities. This surveillance is done to ensure that marketed devices comply with the requirements of the MDR by checking on the conformity characteristics and performance of the devices. Post Market Surveillance (Article 83) is carried out by the manufacturer to systematically collect and review experience gained for their own devices.

Q: Is there a best practice/method for searching for vigilance and FSCAs information for similar products? How far back are they looking for their initial data pull?

A: This will get much easier once EUDAMED is functional and populated as it will provide a central repository for some of this information. Until then, we continue to look at FDA databases and other English-speaking databases (UK, Australia, Canada). For the initial pull, it is suggested to go back five years if the technology has been consistent over that time frame. If, however, something significant has occurred (e.g. move from open to minimally invasive procedures) then limit the search to that time frame.

Q: I am confused about the definitions of "incident" Article 2 (64), "serious incident" Article 2 (65), and "serious adverse event" Article 2 (58). What are the differences?

A: Examples of these would be the following:
incident: this might be when a device applied undo pressure causing temporary pain for the patient
serious incident: the device caused a crush injury that may lead to permanent damage
serious adverse event: the device caused the death of the patient

A key distinction is in the seriousness of the event which, in turn, impacts the reporting time frames. Serious incident reporting timeframes for public health threats is two days. Death or unanticipated deterioration in a person's state of health is to be reported in 10 days. All other serious incidents (that could have led to death or serious deterioration in health) must now be reported within 15 days of becoming aware of the incident.

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Q: I would like to understand the difference between vigilance and PMS. Is vigilance, in terms of vigilance personnel, the collection and reporting of incidents to Competent Authorities and as thus a small part of the PMS?

A: Yes, Vigilance is just one portion of your overall PMS program. Other activities include complaints that do not have to be reported under the vigilance requirements; your CAPAs; Field Safety Corrective Actions (FSCA); and your proactive PMS activities.

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