The Role of Post-market Surveillance in the European Medical Devices Regulation (MDR): Key Questions
Regulatory Updates | Medical Devices
Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS.
Common questions about the MDR PMS approach
As the requirements applicable to medical devices have changed and expanded significantly, certain areas are causing concern regarding expectations for compliance. For PMS, MDR requires manufacturers to be proactive in their efforts to understand field experience. Although some Notified Bodies have already begun to enforce this practice for high-risk devices, for others this is new. As a result, we have received inquiries as to the specifics of what may be expected. Some of the questions, and our responses, are as follows:
- Is the approach of reviewing and analyzing complaints gathered in a manufacturer’s internal database and other databases (e.g., MAUDE) sufficient to satisfy the MDR?
This is a passive approach. While the recitals are explanatory text without legal merit, it is nevertheless important to note the text from item (74) under “Whereas” in the MDR, which says in part:
“Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities…”
The highlighted words are key to establishing expectations here. The regulation was specifically updated to ensure that manufacturers do not passively wait for information to come to them, but instead actively seek out and review information. For most manufacturers, this may involve establishing new, formal processes to solicit information from a variety of sources.
Understanding the use of the information is also helpful when establishing such sources. For example, questions PMS should answer include: “Does the device perform as intended, and is the device safe enough to remain on the market?”
Also, Post-Market Clinical Follow-up (PMCF), a specific form of PMS (not required in all cases) primarily seeks to determine “How can the device or its use be improved?” And certainly, manufacturers should understand that PMS is a total product lifecycle process, meaning that state-of-the-art must be continuously monitored, as the benefit-risk profile can and does change over time.
- Does the MDR specifically mandate that manufacturers go out into the field and ask users about their experience using the device and whether they experience any issues?
The MDR does not specify requirements for information gathering. However, new, formal mechanisms may be needed to actively collect specific types of information from specific sources. That is, traditional approaches of collecting complaint data may be insufficient. For example, consider the level of risk associated with the device, its intended use, the maturity stage of the device (i.e. is this a novel device where a PMCF study is to be conducted, or is this a low-risk device with a long history of clinical performance where the risks are well understood?)
The need for information can vary significantly; accordingly, companies should tailor information-gathering mechanisms to the device in question, the environment in which it is used and its users as appropriate for the need.
- Or maybe the MDR does not specify the approach clearly and it is up to the manufacturer?
In the MDR, Article 83 PMS system of the manufacturer clarifies expectations:
“1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(9). “
That is, it is up to the manufacturer; having said this, the PMS approach should be proportionate to the risk class for the device, substantiated by a sound, well-supported methodology.
Regarding the what and how, some practical recommendations include:
- The manufacturer must identify potential sources of input for PMS (e.g. incidents, data bases, literature, sales contacts etc.);
- Collaborative, cross-functional efforts with clinicians can be established to answer targeted questions to understand the accuracy of benefit-risk estimates, or whether new, off-label uses are occurring;
- Analysis techniques (e.g. trending with defined cut off points, trigger values related to certain characteristics etc.) and triggers for certain actions (e.g. starting a field safety corrective action, issue a design change etc.).
In sum, a one-size-fits-all approach is not appropriate--a graduated approach based on a formal rationale tied to the risk of the device (which can include many factors) should be followed. It is up to the manufacturer to define is the parameters of this methodology, but any such methodology should be well supported.
There are several other areas in Article 83 on PMS that warrant analysis:
“3.Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
(a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
“Benefit-risk” determination is new to the MDR, although MEDDEV 2.7/1 revision 4 certainly provides supporting information. Nevertheless, manufacturers should consider reviewing whether the benefits associated with a device are clearly understood and documented, as this is needed to understand, and will impact, the benefit-risk requirements throughout the MDR.
“(b) to update the design and manufacturing information, the instructions for use and the labelling;”
Aligning with the complaint and design input requirements in ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes, clearly, manufacturers should use information from PMS to update and clarify IFU and labelling information – something that is typically the subject of a usability study.
“(f) for the identification of options to improve the usability, performance and safety of the device;”
This reinforces the need to review for usability issues in PMS.
“(h) to detect and report trends in accordance with Article 88.”
How are trends being identified and monitored? Note that this can and should be used to review and update the benefit-risk determination.
Mark Leimbeck is Program Manager at UL Healthcare.
Additional European MDR and PMS information:
- European MDR gap assessment and transition strategy support
- On-site EU MDR training for manufacturers
- Webinar: Risk management for medical devices in new regulatory environments