Post Market Surveillance (PMS) has been elevated in importance by the new MDR and IVDR regulations which will come into force in the EU from 2021 and 2022. But what will it mean in practice for manufacturers and other operators in the medical device supply chain?
The background to the changes in PMS requirements
It was an international scandal that precipitated many of the changes to medical device regulation that will be introduced by the new EU MDR.
The devastation wrought by the criminal negligence of the French company Poly Implant Prothese was alarming in its scale and the length of time it went unchecked. The company’s use of unapproved PIP implants made from a cheap, industrial-grade silicone saw the devices rupturing at a rate that was double the industry average. As a result, thousands of women around Europe were injured or put at risk, and the founder of PIP was jailed in 2013.
This was part of the market context from which the EU MDR emerged. The new regulatory framework will ensure cosmetic devices are at last subject to oversight in the EU, as well as clamping down on elements of marketing malpractice.
But the changes in the MDR will also mean increased post-market surveillance (PMS) responsibilities for every medical device manufacturer and their associated economic operators.
A proactive paradigm for medical device quality management
The greater emphasis on PMS has been in the pipeline for some time. For many years medical device regulators around the world have been increasingly focused on promoting a proactive approach to quality management, instead of a more passive ‘inspect and correct’ paradigm of regulation. Even so, the effects on the operations of device manufacturer and other Economic Operators in the supply chain will be profound.
What will Post Market Surveillance for medical devices entail?
The EU Medical Device Regulation 2017/746 (MDR) for the first time defines Post Market Surveillance as:
"All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain 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."
Post Market Surveillance, therefore, requires manufacturers and their economic operators to have a documented system in place which can:
- capture and report on adverse events that involve the devices for which they are responsible
- Proactively generate and store feedback about these devices via various mechanisms
To do this effectively (and demonstrate they have a repeatable system for doing so) the regulation requires companies to:
- Document their PMS plans,
- Produce required reports based on those plans
- Make them available to the regulator.
What is the Post Market Surveillance Plan?
The new EU MDR and IVDR regulations require medical device manufacturers to include a Post Market Surveillance plan as part of the technical documentation they submit to the regulator for approval.
What should be in the PMS plan?
Annex III of the MDR specifies the requirements and the contents of a post-market surveillance plan, which will address the collection and utilization of the ‘post-market information’.
This information includes user feedback, trend reports, clinical follow-up data, and the like. The plan should cover:
- The appropriate statistical and analytical methods a company has in place for assessing collected data
- Documented threshold values for assessing risk-benefit and effective risk management
- Appropriate systems and tools for investigating complaints and other experience collected in the field
- Documented protocols for communicating effectively with the competent authorities, notified bodies, economic operators, and users
- Procedures to fulfil the manufacturer's obligations for a PMS system, PMS plan, PMSR (Post Market Surveillance Report) or PSUR (Periodic Safety Update Report).
- Documented procedures and systems for implementing Corrective Actions when required
- Tools to trace and identify devices for which corrective actions may be needed (traceability of potentially defective products in case a recall is needed, for example)
Annex 3 also requires companies to supply:
- “a Post-Market Clinical Follow-up (PMCF) plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.”
PMSR or PSUR?
As mentioned above, the implemented plan should result in the production of a PMS report (PMSR) or Periodic Safety Update Report PSUR) - depending on the class of the device involved.
What should the PMSR include?
A PMSR must be produced by those responsible for
- Class I medical devices (under the MDR)
- Class A and B devices (under the IVDR)
PMSRs should present
(i) results and conclusions of data gathered from the post-market surveillance plans
(ii) a description of any corrective and preventive actions taken.
The documentation should be available for inspection at the manufacturer’s site and be available to a competent authority upon request.
What should the PSUR include
A PSUR must be produced by those responsible for:
- Class IIa, IIb and III medical devices (as defined by the MDR)
- Class C and D in-vitro devices ( as defined by the IVDR)
It should include:
(i) Conclusions of the benefit-risk determination,
(ii) The main findings of the post-market clinical follow-up
(iiii) Volume of sales of the device together with information on the population using the device.
The PSUR is part of the technical documentation and must be updated regularly. This means at least every two years for class IIa devices and annually for class IIb and class III devices.
It should be noted that for implantable devices (Class IIb) and Class III devices, submission to notified bodies will be through Electronic submission via Eudamed
Post-Market Clinical Follow-up (PMCF)
As mentioned above, PMCF is now a significant part of the PMS responsibilities for certain device types.
Manufacturers should base their PMCF process on a PMCF plan. The findings of the PMCF must be documented in a PMCF evaluation report which, in turn, should form part of the Clinical Evaluation Report (CER) and the technical documentation.
PMCF activities are intended to:
- confirm safety and performance of device
- identify unknown side-effects of device usage
- identify contraindications or risks
- ensure continued acceptability of the benefit-risk ratio
- Identify the risks of off-label use-misuse
- address specific goals in the CER
Post-market data must be used to continually reassess the benefit–risk analysis in the CER and to update the risk management part of the technical documentation.
Any actions such as recalls and notifications have to be discussed in the PMCF evaluation report. Incidents should be displayed in a table and (serious) adverse events mentioned in detail - with a focus on the evaluation of whether an incident is device-related or not.
For Class III devices and implantable devices, the PMCF evaluation report is required to have annual data updates.
This was just a brief look at the new responsibilities thrown up for manufacturers and other economic operators in the medical device chain by the MDR and IVDR.
But one thing is very clear from looking at the regulatory literature,’the post-marketing surveillance system [is] an integral part of [an] organisation’s quality management system” (see. Art. 83 of MDR and Art.78 of IVDR).
To be ready to meet these PMS requirements those responsible for medical devices need to have the means of publishing, controlling and auditing the documentation and systems that can oversee the safety of a product throughout its lifecycle. This means ensuring you have the tools to continually monitor the risk a device poses to users, based on your vigilance and the proactive gathering of feedback around the usage of your device. The effectiveness of your QMS will be key to delivering on these obligations and demonstrating to regulators that you have done so.