Market surveillance is the activity conducted by European Competent Authorities to ensure that medical device safety, quality, performance, and compliance requirements are met.
Market surveillance is defined in MDR article 93 and IVDR article 88, as “appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples.“
In particular, the competent authority reviews the safety and performance of medical devices and in vitro diagnostic devices (IVDs) against risk assessment and management, vigilance data, and complaints.
The competent authority’s market surveillance program includes:
While market surveillance is conducted by the EU competent authorities, post-market surveillance is the process by which manufacturers ensure the continued safety and performance of a medical device or IVD.
A key starting point for post-market surveillance under the MDR (Article 83) and IVDR (Article 78), is that it should be proactive. i.e., the system should not only passively collect and react to feedback and market information as received; it should additionally actively seek out post-market data.
The resulting analysis of the gathered data should help the manufacturer identify any updates needed to the: device benefit-risk profile, design, manufacturing information, instructions for use & labeling, clinical evaluations, risk management documentation, and/or the summary of safety and clinical performance.
Further, the analysis should be used to help identify the need for any preventive or corrective actions. As well, any options to improve the usability, performance, or safety of the device. Data should also contribute to identifying opportunities to improve other devices, as well as detect and report trends in accordance with articles 88 (MDR) and 83 (IVDR). (More on trend reporting is provided below.)
The post-market surveillance program remains in place throughout the device’s lifetime. This is to ensure it remains compliant while it is on the market. The amount and range of data collected should be directly proportionate to the risk class of the device and its intended use. A sound post-market surveillance system also contemplates any shortcomings in the design and development of the device and makes sure to address them.
The post-market surveillance plan is the protocol for the overall post-market surveillance system. It establishes the procedure to follow for all associated post-market surveillance processes.
Post-market surveillance plan requirements are outlined in Annex III of the MDR and IVDR and are similar for medical devices and IVDs.
The post-market surveillance plan should address the collection and utilization of the following:
The plan should also address how it will proactively and systematically collect the above information.
Further, it should:
The post-market surveillance plans should be established before placing the device on the market and be updated throughout the lifetime of the device as needed.
A Post-market Surveillance Report is only required for manufacturers of Class I medical devices and Class A and B IVDs.
It is intended to:
The post-market surveillance report should be updated when necessary and made available to the competent authority upon request. It is generally recommended to update the post-market surveillance report every three years, whether the competent authority requests to review it or not.
|Table 1: Requirements for PMS reports under the MDR and IVDR|
|Type of device||MDR / IVDR Classification||Type of report||Submission||Updates required|
|Medical Device||Class I||PMS||Upon request||When necessary, best practice is at least every three years|
|IVD||Class A, B||PMS||Upon request||When necessary, best practice is at least every three years|
A Periodic Safety Update Report (PSUR) is required for manufacturers of Class IIa, IIb, and III medical devices and Class C and D IVDs.
Those manufacturers must generate a robust report that:
The periodic safety update report should be available upon request from the competent authority or notified body. The exception is for Class III and Class IIa/IIb implantable devices and Class D IVDs, for which the PSUR should be submitted to the notified body.
Manufacturers of Class IIa medical devices and Class C IVDs must update the PSUR when necessary, but at least every two years. In contrast, manufacturers of Class IIb and Class III medical devices and Class D IVDs must update the PSUR at least annually.
|Table 2: Requirements for PSUR under the MDR and IVDR|
|Type of devices||MDR / IVDR Classification||Type of report||Submission||Updates required|
|Medical Device||Class IIa
|PSUR||Only upon request||At minimum every two years|
|Class IIa (Implantable)||PSUR||To the Notified Body||At minimum every two years|
|PSUR||Only upon request||At minimum every year|
|PSUR||To the Notified Body||At minimum every year|
|Class III (all)||PSUR||To the Notified Body||At minimum every year|
|IVD||Class C||PSUR||Only upon request||At minimum every two years|
|Class D||PSUR||To the Notified Body||At minimum every year|
For ease of use, Casus transposed the MDCG PSUR Template (Annexes I, II, III and V) into word format so they are easily editable by the user. We also created one master template with additional help text.
The templates are available here: Tools & Templates
Post-market Clinical Follow-up (PMCF) is the continuous process of updating the clinical evaluation of a medical device. The corresponding process for IVDs is Post-market Performance Follow-up (PMPF), which aims to update the performance evaluation. These processes are described in Part B of Annex XIV and Part B of Annex III in the MDR and IVDR, respectively.
For this overview, we will refer to both processes as post-market clinical follow-up (PMCF) as they fulfill a similar purpose.
PMCF is addressed in the post-market surveillance plan as an integral part of the overall post-market surveillance program. Like post-market surveillance, PMCF aims to confirm the safety and performance throughout the device’s lifetime and to ensure the continued acceptability of the benefit-risk profile. However, while post-market surveillance is focused on all aspects of safety and performance, PMCF is focused on the clinical aspects of performance and safety. It consists of collecting clinical data to confirm and update the information described in the clinical evaluation for medical devices and the performance evaluation for IVDs. This could include identifying previously unknown side effects, monitoring already identified side effects, or identifying and analyzing emergent risks.
A PMCF Plan should include the following (non-exhaustive):
Once the PMCF plan has been executed, the findings of the PMCF should be included in a PMCF report. That report then forms part of the clinical evaluation report. The PMCF Plan should be part of the Post-market Surveillance Plan.
A PMCF/PMPF is required unless the manufacturer can justify its non-applicability. Notified Body BSI has released a White Paper, which states that “the European system has designated that if a device has gained CE Marking based on equivalency (even if the equivalent devices have long-term data that demonstrates their safety and performance) – PMCF will likely be required.” However, if a manufacturer “provided long-term clinical data that demonstrates state-of-the-art safety and performance for its intended use, PMCF may not be necessary.” The White Paper is located: HERE
With the MDR and IVDR, trend reporting became a vital part of post-market surveillance procedures in the EU. The two regulations are the first in the world to require trend analysis and the reporting of increases in the frequency or severity of certain types of incidents that are:
Typically the manufacturer is aware of the potential for the above non-serious incidents or expected undesirable side-effects, identified during product design and/or risk analsyis.
Trend reporting is a way for the manufacturer and competent authority to catch trends in:
Any emerging trends should be analyzed through the statistical methods established in the post-market surveillance plan. They should be compared to the expected frequency or severity of incidents and weighed against the intended benefit.
For trend reporting to be used accurately, the manufacturer must gather the basic trend parameters: number of events, time period, and the number of used devices. Other parameters, such as the age and gender of the patient, or the age of the device, can be relevant for some devices, depending on the intended use and application.
Determining trends includes establishing baseline and threshold values against which the frequency and severity of incidents can be compared. While there is very little guidance on a “significant increase” in a trend, it is generally considered to be a rapid and continuous increase for high-volume products or a slow and continuous increase for low-volume products.
Additionally, ideally trend reporting would be performed on similar devices on the market. This is to obtain a baseline and panoramic image of post-market behavior for the device, which the manufacturer can use to evaluate the benefit-risk profile.
Medical device and IVD vigilance is the process of reporting serious incidents and field safety corrective actions (e.g., recalls) to Competent Authorities.
In the MDR and IVDR:
The vigilance obligations for medical and in vitro diagnostic devices are the same for all intents and purposes. There are no differences in reporting processes or deadlines between the two regulations.
Any serious incidents involving a device available in the European Union must be reported. When EUDAMED is fully functional, incident reports shall be entered into the Vigilance and Market Surveillance module. In the meantime, incidents shall be reported directly to the relevant competent authorities.
FSCAs involving a device made available on the European Union must also be reported. An additional requirement is that any FSCA undertaken in a third (i.e., non-EU) country for a device on the EU market must also be reported in the EU unless that FSCA is limited to the device made available in the third country. Most competent authorities publish FSCA information on their websites for public awareness. For example, Ireland’s Health Products Regulatory Authority (HPRA) website: Safety Notices/Communications
Reporting timeline depends on the severity of the incident and its potential repercussions.
|Table 3: Timeframes to report incidents under the MDR and IVDR|
|Type of Incident||Timeframe to Report|
|Serious public health threat||No later than 2 days after the manufacturer becomes aware of the threat|
|Serious incident involving death or serious deterioration in a person’s health||No later than 10 days after the manufacturer becomes aware of the incident|
|Serious incident||No later than 15 days after the manufacturer becomes aware of the incident|
Since the reporting timelines are relatively short, the initial report can be incomplete and lacking information until a proper investigation has been performed, after which the full report can be submitted.