The Post-Market Surveillance Document: Which Ones Do you Need?
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
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 a system for detecting, analyzing, evaluating, and understanding the benefits and risks associated with the use of a medical device. 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 gather information about all adverse events that have occurred during the use of a product, including any event that was not known at the time of authorization.
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 The Post-Market Surveillance process
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, auditing, and evaluating the performance and safety of devices, including information from national authorities, patients (adverse event reports), healthcare providers, manufacturers, and importers.
-Regular inspections of manufacturers’ facilities
-Testing samples or batches of devices
-Inspection of documentation
-Product recall or stop sale (including withdrawal from the market)
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 documents required for PMS submission are:
- 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.
- Information regarding data assessment and reassessment.
- Information regarding incident/adverse events etc., investigation, and how you plan to manage them
- Information regarding communication with authorities
- Information regarding procedural details
- PMCF plan
- PSUR where applicable
PMS Medical Devices
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 must prepare annual PMS reports for medium to high-risk devices and submit them to regulators annually or 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:
- Annex III (MDR): Technical documentation on post-market surveillance – Medical Device Regulation WebApp English language (tuvsud.com)
