In February – just before COVID-19 began to seriously impact those of us in the United States – R&Q Executive Director of Regulatory & Quality Consulting Services, Nancy Morrison, presented the webinar PMS Requirements of the EU MDR: Implementation Challenges and Solutions.
We received a ton of excellent questions during that webinar and in this blog post, we'd like to publicly share our answers to many of them. We hope you find them helpful! If you haven't seen this webinar yet, here's a link where you can sign up to view the on-demand version (and download the slides).
If you have specific questions in this area, please contact us.
Q: PMS and PMCF requirements overlap significantly. What is the difference between the two concepts?
A: The PMCF is a subset of the PMS data. The PMS includes both reactive data (complaints) and proactive data (surveys, registries, clinical studies). The PMCF data is the proactive data that is collected.
Q: What is the difference between a PMCF plan and a clinical development plan?
A: The clinical development plan is an outline of all planned clinical studies and is typically initiated prior to launch of the product. It would include the studies that are going to be collected as evidence in order to put the device on the market and additional information that will be collected after it is on the market. The PMCF plan will just include data that is to be collected after the product is on the market. There can be overlap between the two.
Q: For MDD class I devices that fall under the corrigendum for transitional provisions (need to up-classify under the MDR ruleset to IIa or above), does the PSUR requirement apply during the transition period or only after the EC cert is issued?
A: Class I reusable surgical instruments that have been extended under the corrigendum still require PMS plans and reports as of the date of applicability (May 26, 2020).
Q: Would be interested in understanding responsibility for manufacturer to surveil off label use and provide trend reporting on it.
A: One of the objectives of PMCF is to monitor for off-label use. If you are seeing off-label use, then yes you do need to trend that usage and react. Expectation is that you either expand your indications and gather the evidence to support or take other action to prevent use in that way if it is not safe and effective. This would feed into your risk management documentation.
Q: What kind of manufacturing changes should be included in the PSUR/PMS reports?
A: The focus would be on things that could affect the safety and performance of the device. If you changed from molded components to 3-D printing that would be significant and need reported. If you replaced a piece of equipment with a like piece of equipment, I would not consider that significant. Minor changes to SOPs that clarify operations would not be included. Adding additional testing of finished devices is something I would include especially if it was done to address quality issues.
Q: How should the CAPAs related to product be linked in with the PMS/PSUR reports?
A:Typically you would start with a report and then remove those that aren't likely to impact safety or performance. For example, a failure of an employee to follow procedure but all the product was contained and none were released to the field may be an example of one that would not be expected to impact the product. On the other hand if you have a situation where a piece of equipment was replaced with a different type of equipment without prior validation, that could be envisioned to impact the product that has been shipped. Correction may include validation reducing the risk but would still warrant consideration to see if it aligned with an increase in post market complaints.
Q: Are PSURs required indefinitely then for implants, which can be in use for decades?
A: Yes, they are expected for the life of the device. In reality, the amount of data that you collect will diminish each year and it is reasonable to justify a reduced plan to correspond with the declining feedback on the device.
Q: Are literature searches considered proactive or reactive activities?
A: In the regulations, appendix XIV, it lists literature searches as one method of PMCF which is considered proactive. If on the other hand, you are looking at literature as part of an investigation into increased complaints that would be a reactive literature search.
Q: If we have a significant increase, are we obligated to submit a vigilance form?
A: Yes, if there is an increase in incidents or an increase in the severity of the incidents it would be reportable. Reference Article 88 for trend reporting.
Q: Can you please elaborate on your success using literature review as PMCF? BSI has published a white paper saying literature review is a reactive activity.
A: We have submitted files to BSI with literature as a proactive study. However, we will say that it was not the ONLY form of PMCF so it may be a situation where the total story was adequate and not that one particular activity is acceptable.
Q: If you have a family of similar devices, all with the same intended use, does each device need a PMS and a PMCF Plan? Or can a single PMS Plan and a single PMCF Plan cover the entire family -- provided each type is clearly described?
A: It is possible to do PMS and PSURs on a family of devices. When you get to SSCP if applicable, the guidance states that all the devices in the document need to have the same Basic UDI. In order to reduce risk, we would recommend assigning a single B-UDI to the family of devices that will be used in a PMS plan or PMCF.
Q: What if you submit a MIR to meet the 15-day timeline, but the investigation reveals that your device wasn't at fault? Germany scolded me when I submitted a follow up report indicating this.
A: The regulation does allow for follow-up submissions once additional information is gathered. One advantage going forward may be that these will be submitted to EUDAMED instead of individual member states that may interpret the requirements differently.
Q: Do you recommend IMDRF coding all complaints or only reportable complaints
A: We would recommend using the IMDRF coding for all complaints. It will give a consistent methodology for trending, reporting and analyzing the data in a consistent manner across all reports.
Q: Can a PMS plan be shared to many similar devices?
A: There is nothing in the regulation that prohibits multiple devices in a single report and it makes sense to group devices by indication. The SSCP guidance does state that if multiple devices are to be listed then they must use the same Basic UDI. To be safe, we would consider a single B-UDI for the devices in the one report.
Q: Please provide a link to the IMDRF codes.
A: Here is the link to the MedTech Europe site, as it has a nice outline of the codes and links.
Q: Where do you look up the mdr common specifications?
A: We would monitor both the Europa New Regulations section of their website and monitor the Official Journal of the European Union for consultations regarding common specifications. This is where the draft common specification on reuse of single use devices was published.