Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

The EU Medical Device Regulation: Post Market Surveillance

The EU Medical Devices Regulation (MDR) goes into effect on May 21st. The MDR takes more of a life-cycle approach than the Medical Devices Directive (MDD), which focused on the pre-approval stage of medical device manufacturing. One area which shows significantly increased emphasis over the MDD is Post-market Surveillance. The word “safety” appears 40 times in the MDD and 248 times in the MDR. The term Post-market Surveillance only appears twice in the MDD, it appears 57 times in the MDR. Certain activities which were undefined in the MDD are fully detailed in the MDR.

For example, the MDD did not define Post-market Surveillance (PMS). However, it did refer to post-market surveillance as “an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X.” The first of the provisions in Annex X is that the “clinical evaluation and its documentation be actively updated with the data obtained from the post-market surveillance.” The second provision is that Post-market Surveillance must include Post-market Clinical Follow-up (PMCF) unless not doing so could be justified. No details are provided in the MDD as to what constitutes a PMCF. The PCMF Plan is mentioned only once in the MDD and it too is not detailed.

The MDR filled in a number of gaps in the MDD by providing detail on the requirements for PMS and PMCF. The MDR provides a definition of Post-market Surveillance. It is defined as “all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”

There are two critical phrases in the PMS definition. The first is “systematic procedure.” Thus, a Post-market Surveillance Plan is required. And the findings of the post-market surveillance are to be reported. The reporting takes the form of one of two new documents, i.e., the PMS Report for Class I devices and the Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices.

The second critical phrase is “proactively collect.” it is not sufficient to merely rely upon complaints that are received as a measure of how your device is performing in the field. You must go out and collect, in some fashion, the full field experience with your device.

The MDR specifies that the data collected by the PMS system is to be used to:

  • update the benefit-risk determination and to improve risk management;
  • update the design and manufacturing information, instructions for use, and labelling;
  • update the clinical evaluation;
  • update the summary of safety and clinical performance;
  • identify the need for preventive, corrective or field safety corrective action;
  • identify options to improve the usability, performance, and safety of the device;
  • when relevant, to contribute to the post-market surveillance of other devices; and
  • to detect and report trends

The MDR does not include a definition of PMCF. However, it does describe PMCF as a “continuous process” in which a manufacturer “shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears CE marking and is placed on the market or put into service within its intended purpose’ with the “aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.” The purpose of a PMCF is to:

  • confirm the safety and performance of the device throughout its expected lifetime,
  • identify previously unknown side-effects and monitor those side-effects and contraindications,
  • identify and analyze new risks,
  • ensure that the benefit-risk ratio is acceptable, and
  • identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

The MDR details the requirements for the PMS Plan and for the PMCF Plan. The PMS Plan should address the collection and use of the following information:

  • serious incidents, including information from PSURs, and field safety corrective actions;
  • non-serious incidents and data on any undesirable side-effects;
  • trend reporting;
  • relevant specialist or technical literature, databases and/or registers;
  • feedback and complaints from users, distributors, and importers; and
  • publicly available information about similar medical devices.

The PMS Plan should include:

  1. a proactive and systematic process to collect the information referred to above. The process should allow a correct characterization of the performance of the devices and should also allow a comparison to be made between the device and similar products available on the market;
  2. effective and appropriate methods and processes to assess the collected data;
  3. indicators and threshold values that may be used to reassess the risk/benefit analysis and risk management;
  4. effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field;
  5. methods and protocols to manage the incidents subject to trend reporting, including the methods and protocols to be used to establish a statistically significant increase in the frequency or severity of incidents as well as the observation period;
  6. methods and protocols for communication with competent authorities, notified bodies, economic operators and users;
  7. reference to procedures with respect to a Post-market Surveillance System and a Post-market Surveillance Report;
  8. systematic procedures to identify and initiate appropriate measures including corrective actions;
    effective tools to trace and identify devices for which corrective actions might be necessary;
  9. a PMCF plan or a justification as to why a PMCF is not applicable; and
  10. the PSUR or the PMS Report

The PMCF Plan details how the PMCF is to be carried out. The PMCF plan must specify the methods and procedures for proactively collecting and evaluating clinical data. The PMCF plan must include the following:

  1. general methods and procedures, such as collecting clinical experience, user feedback, and review of the scientific literature, review of device registries, PMCF studies, and other sources of clinical data;
  2. rationale for the appropriateness of the methods and procedures utilized;
  3. reference to the relevant parts of the clinical evaluation report and to your risk management system;
  4. objectives of the PMCF;
  5. evaluation of clinical data from equivalent or similar devices;
  6. reference to relevant Consensus Standards, harmonized standards used, and relevant guidance on PMCF; and
  7. detailed and justified time schedule for PMCF activities, e.g., analysis of PMCF data

The conclusions of the PMCF evaluation report are to be part of the clinical evaluation and the risk management system. If the PMCF indicates that preventive and/or corrective measures are necessary, identified, they are to be implemented.

In summary, the MDR provides the detail on Post-market Surveillance that the MDD lacked. The Post-market Surveillance requirements are significantly more onerous under the MDR than they were under the MDD. This is consistent with the MDR’s life-cycle approach to medical devices and emphasis on safety. Post-market Surveillance must be well planned, and its execution must reflect a proactive approach.

Mike Andrews, Ph.D., former Vice President, Regulatory and Quality, Boulder iQ