The Post-Market Surveillance Document: Which Ones Do you Need?

Under EU MDR, PMS documentation comes down to four core documents: a PMS plan for every device (Article 84), a PMCF plan and PMCF evaluation report or a justification for not needing them, and either a PMS Report for Class I devices (Article 85) or a Periodic Safety Update Report for Class IIa, IIb, and III devices (Article 86). All of them sit in the PMS technical documentation described in Annex III. For how the PMS system itself works, start with our main guide to post-market surveillance under EU MDR.

It’s not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, including devices that have been incorporated or are intended to be incorporated into a medical device system (i.e., active implantable medical devices). Post-market surveillance aims to monitor the safety of medical devices that have been approved for use by patients, as well as identify any potential issues or concerns related to their use.

Not only does the EU require you to submit how you will carry out the post-market surveillance for your product, but it also has some terms and conditions you need to fulfill while submitting them. Furthermore, it is required to be submitted in the form of a technical document. According to Annexe iii of MDR, the technical documentation required by the EU on PMS should be ” clear, organized, readily searchable and written in an unambiguous manner” if that sounds explicit yet vague to you, no worries. Here is a breakdown of what this entails.

Definition of The Post-Market Surveillance

MDR Article 2(60) defines PMS as the manufacturer’s proactive, systematic collection and review of experience with its marketed devices, to spot any need for corrective or preventive action.

The European Union Medical Device Regulation (EU MDR) requires the holder of a CE Mark to have an effective post-market surveillance system in place. The EU MDR defines post-market surveillance 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. This is important because it requires a medical device manufacturer to identify risks associated with their products after they have been put into use by patients or healthcare professionals.

Post-market surveillance ensures that new risks are identified and addressed before they become widespread or cause damage to patients or healthcare professionals. The purpose of the Post Market Surveillance report is to summarise the results and conclusions of analysing the PMS data collected for the device, together with the rationale for, and description of, any preventive or corrective actions taken (Article 85).

Also, the EU expects you to use this information to improve the device’s safety and performance further. The European authority recommends that you establish a feedback system so that you can monitor how people are using your product and address any issues that arise. This can be done by using an online form or by sending out questionnaires through email.

You should also prepare your tracking and reporting system so that you can provide information on any adverse reactions or other adverse events associated with your product. These are all part of the PMS system and should be planned before launching the device.

Requirements for Post-Market Surveillance process

A manufacturer’s PMS process collects data from incidents, complaints, literature, registries, and similar devices, and uses it to improve the device; inspections and recalls ordered by regulators are a separate authority function.

The European Union Medical Device Regulation (EU MDR) has set forth several requirements for post-market surveillance. Unfortunately, this topic is often misunderstood, so here are a few facts to help you better understand the specifics.

Post-market surveillance activities may include:

• Monitoring and evaluating the performance and safety of devices, using information from national authorities, patients (adverse event reports), healthcare providers, distributors, and importers
• Reviewing complaints, user feedback, and non-serious incidents for trends
• Screening scientific literature, registries, and databases for data on the device and similar devices
• Running post-market clinical follow-up (PMCF) activities
• Initiating corrective and preventive actions, including field safety corrective actions such as recalls, where the data shows they are needed

For what competent authorities do, see the market surveillance section of our main PMS guide [link: /post-market-surveillance-under-eu-mdr/].

In short, the PMS processes should target improving the medical device based on finding the market. And the PMS plan needs to reflect that. All post-market surveillance document requirements are kept with this in mind. The required documents all flow from the core framework for post-market surveillance under EU MDR, which our main PMS guide explains in full.

The documents required for PMS submission are:

1. An outline of how you are planning to collect and use data regarding:
   • Information regarding serious incidents, including information from PSURs, and FSCAs (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 feedback and complaints, provided by users, distributors, and importers
   • Publicly available information about similar medical devices.
2. Information regarding data assessment and reassessment.
3. Information regarding incident/adverse events etc., investigation, and how you plan to manage them
4. Information regarding communication with authorities
5. Information regarding procedural details
6. PMCF plan
7. PSUR where applicable

PMS Documents at a Glance

Every device needs a PMS plan and a PMCF plan or justification; Class I adds a PMS Report, Class IIa to III add a PSUR, and vigilance and trend reports are event-driven.

PMS Medical Devices

How often PMS activities run depends on device type, risk class, and intended purpose, with higher-risk devices reviewed and reported on more often.

The frequency of post-market surveillance activities shall be based on the type of device, its risk class, and its intended purpose. The regulatory requirements for post-market surveillance activities are set out in Annex III and articles 83 to 87 of this Regulation.

Each type of medical device has an assigned risk class based on how likely it is to cause harm to a patient if misused or if it fails during use. The higher the risk class level assigned to a device, the more frequently it should be subject to post-market surveillance activities.

The periodic safety update report is not required for Class I medical devices. Just the fact that the PMS plan is undertaken as said is enough. However, the class ii and class iii devices require PSUR, risk/benefit determination, PMCF details, main findings, etc.

Manufacturers of Class IIb and Class III devices must update their PSUR at least annually, and manufacturers of Class IIa devices at least every two years. For Class III and implantable devices the PSUR is submitted to the notified body for evaluation; for other classes it is made available to the notified body and, on request, to competent authorities. Class I devices need a PMS Report instead, updated when necessary and made available to competent authorities on request.

Annual reporting for each year usually includes a summary of the information collected for each device. Mostly the information collection is done in two methods. The Post-market clinical follow-up provides accurate clinical data analysis, while the vigilance system allows the company to react to complaints, adverse effects, etc.

These data are then used to update and improve upon the medical device’s performance, risk management, add/change to the user manual, and evaluate the need for and perform Preventive And Corrective Actions.

References:

1. Annex III (MDR): Technical documentation on post-market surveillance – Medical Device Regulation WebApp English language (tuvsud.com)

FAQ

What PMS documents are required under EU MDR?

Every device needs a PMS plan and a PMCF plan (or a documented justification for not needing one). On top of that, Class I devices need a PMS Report and Class IIa, IIb, and III devices need a Periodic Safety Update Report. Vigilance reports and trend reports are added whenever a reportable event or trend occurs.

What are the PMS report types?

There are two periodic report types: the PMS Report (PMSR) for Class I devices under Article 85, and the Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices under Article 86. The PSUR is the more detailed of the two and must also include the benefit–risk conclusion, the main PMCF findings, sales volumes, and an estimate of the population using the device.

Where do post market surveillance documents sit in the technical documentation?

Annex III of the MDR defines a separate block of technical documentation for PMS, alongside the main technical documentation in Annex II. It contains the PMS plan, the PMCF plan, and the PMSR or PSUR, and it must be presented in a clear, organised, readily searchable, and unambiguous way.

Does a Class I device need a PSUR?

No. Class I devices need a PMS Report instead, which summarises PMS results and any corrective actions and is made available to competent authorities on request. They still need a PMS plan and a PMCF plan or justification.

How often does EU MDR PMS documentation need to be updated?

The PMS plan and PMS Report are updated when necessary. PSURs are updated at least every two years for Class IIa devices and at least annually for Class IIb and III devices. For how these documents fit into the wider PMS system, see our main PMS guide.