EU MDR - Significant Impacts on Post-Market Surveillance

Stefanie Wichansky

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Mar 21, 2018 10:06:00 AM

EU MDR Critical Impacts to Post-Market Surveillance

With the introduction of the European Union Medical Device Regulation (“EU MDR”) in May 2017, medical device companies have been scrambling to fully understand the impact on their organizations, as well as the actions and resources needed to ensure timely compliance (see our blog EU MDR - A Call to Action for Manufacturers). The EU MDR is complex and voluminous, carrying several significant changes as compared to the previous directive such as expanded guidance around clinical evidence, new labeling requirements, heightened focus on post-market surveillance, enhanced supplier monitoring activities, and increased monitoring and procedures from Notified Bodies, to name a few. Here, we will drill down on post-market surveillance to highlight some of the more noteworthy items in this particular section of the EU MDR. 


The new EU MDR is very prescriptive and eliminates many of the grey areas and subjective interpretation that companies dealt with under the previous directive. Now there is an explicit definition of post-market surveillance (“PMS”) as follows: “post-market surveillance means 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.” Further, PMS is specifically called out in the EU MDR as one of the general requirements for medical device manufacturers, and it is referenced as one of the duties of the person designated as the individual responsible for regulatory compliance. Bottom line – the regulators have made a concerted and clear effort to emphasize PMS and convey its importance.  

Some of the more critical stipulations in the EU MDR impacting PMS are as follows:

1) For each medical device, the manufacturer must document, maintain, and update a PMS System which aligns with the risk associated for the particular device type. As described in Article 83, the data gathered by the PMS System should be used:

(a) to update the benefit-risk determination and to improve the risk management;
(b) to update the design and manufacturing information, the instructions for use and the labelling;
(c) to update the clinical evaluation;
(d) to update the summary of safety and clinical performance;
(e) for the identification of needs for preventive, corrective or field safety corrective action;
(f) for the identification of options to improve the usability, performance and safety of the device;
(g) when relevant, to contribute to the post-market surveillance of other devices; and
(h) to detect and report trends.
 
Click HERE for Overview of Critical Medical Device Standards
2) Each manufacturer should employ a PMS Plan, which will be part of the technical documentation (except for custom-made devices). As described in Annex III of the EU MDR, the PMS Plan should address the collection and utilization of available information including: information concerning serious incidents, including information from Periodic Safety Update Reports (see further discussion on these reports below) and field safety corrective actions; records referring to non-serious incidents and data on any undesirable side-effects; information from trend reporting; relevant specialist or technical literature, databases and/or registers; information, including feedbacks and complaints, provided by users, distributors and importers; and publicly available information about similar medical devices.
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Annex III additionally states that the post-market surveillance plan shall cover at least the                        following:

  • a proactive and systematic process to collect any information. The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
  • effective and appropriate methods and processes to assess the collected data;
  • suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit/risk analysis and of the risk management;
  • effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field;
  • methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
  • methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
  • reference to procedures to fulfill the manufacturers obligations;
  • 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; and
  • a Post-Market Clinical Follow-Up Plan (“PMCF”) (the PMCF is described in Part B of Annex XIV in the EU MDR), or a justification as to why a PMCF is not applicable.

3) For Class I medical devices, manufacturers must prepare a PMS Report which details the results and conclusions derived from the post-market data gathered from the PMS Plan, as well as a description and rationale for any CAPA’s taken. The PMS Report should be updated regularly and made available to the applicable authorities upon request.

4) For Class IIa, IIb, and III medical devices, manufacturers must prepare a Periodic Safety Update Report (“PSUR”) for each device, which describes the results and conclusions derived from the post-market data gathered from the PMS Plan, as well as a description and rationale for any CAPA’s taken. As detailed in Article 86 of the EU MDR, the PSUR must include:

  • the conclusions of the benefit-risk determination;
  • the main findings of the PMCF; and
  • the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Manufacturers of Class IIa devices must update the PSUR at least every 2 years, while manufacturers of Class IIb and III devices must update the PSUR at least annually. The PSUR must be part of the technical documentation, except for custom-made devices which have separate documentation requirements.

Post-market surveillance represents one of several focus areas within the new EU MDR. Quality and Regulatory Compliance professionals need to get educated on the new requirements quickly, so they can conduct effective gap assessments, and then determine the action steps and resources needed to both achieve and then maintain compliance. As part of this process, leaders will need to carefully assess the expertise, skill sets, and availability of their in-house talent and determine the nature and degree of external assistance to bring onboard. As is the case with the many new regulations impacting the medical device industry, the key is to get started early and get the right people involved.

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