PMPF Under the IVDR: Methods, Justifications, and Triggers

As we have mentioned in a previous article (available here), post-market performance follow-up (PMPF) under the in-vitro diagnostic regulation (IVDR) is not limited to PMPF studies but includes both general and specific PMPF methods/procedures, with a strong degree of overlap between post-market surveillance (PMS) activities/information and that generated by general PMPF general methods/procedures. 

These methods/procedures include: 

• General methods/procedures 
  • Gathering of clinical experience gained 
  • Feedback from users 
  • Screening of scientific literature and of other sources of performance or scientific data 
• Specific methods/procedures 
  • Ring trials and other quality assurance activities 
  • Epidemiological studies 
  • Evaluation of suitable patient or disease registers 
  • Genetic databanks 
  • PMPF studies

Justifying a PMPF under the IVDR

We have also noted that one of the common deficiencies we observe in IVDR Technical Documentation Files pertains to manufacturers not appropriately justifying why they do not perform PMPF for a particular device. Under the IVDR, there are two locations in which manufacturers must establish appropriate justification for not performing PMPF which include: 

• PMS Plan (per the last indent of Section 1(b), Annex III) 
• Performance Evaluation Report (per Section 8, Part B, Annex XIII) 

In the case of general PMPF methods/procedures, as there is a strong degree of overlap with PMS information and PMS is mandatory under the IVDR (irrespective of device class), this can be challenging for manufacturers. An appropriate justification should ideally be directly linked to the specific purposes of PMPF and allow for the definition of “trigger” conditions which, if fulfilled, would invalidate the justification and require the realization of general PMPF methods/procedures.  

For example, where the manufacturer has performed the following in performance evaluation, this could be considered a reasonable justification for not performing general PMPF methods/procedures under the IVDR: 

• Confirmed the safety, performance and scientific validity of the device 
• Ensured the acceptability of the benefit-risk ration 
• Demonstrated that the device is well-established with extensive clinical experience (typically including ≥ 10 years of clinical experience) over which timeframe: 
  • There have been no changes in safety, performance and scientific validity 
  • There have been no changes in the acceptability of the benefit-risk ratio 
  • There have been no previously unknown or emerging risks identified, including no changes to limits to performance and contra-indications or instances of systematic misuse 

What can “trigger” a PMPF?

However, it would be strongly recommended that such a justification be accompanied by the following statement (or similar) regarding PMPF “triggers”: 

Where, through the course of the established PMS process, the manufacturer becomes aware of information that contradicts the above justification (e.g. identification of previously unknown or emerging risks), this justification will no longer be valid and the manufacturer will establish a PMPF Plan documenting the manufacturer’s PMPF methods/procedures for the subject device. 

To be able to appropriately verify the existence of such “triggers” it would be critical to ensure that the PMF process includes the verification of data that could potentially activate such “triggers”. 

In the case of specific PMPF methods/procedures under the IVDR, it is typically easier to justify why such methods are unnecessary for a device as this is generally directly related to the clinical evidence, including scientific validity, analytical performance, and clinical performance data gather and analyzed within the scope of performance evaluation and conclusions of the Performance Evaluation Report. For example, as PMPF is used to confirm the safety, performance, and scientific validity of the device and ensure the acceptability of the benefit-risk ration, if it is already confirmed during performance evaluation and risk management that these requirements are fulfilled, and there are no residual risks that impact the benefit-risk ration, then this is typically sufficient justification for not performing specific PMPF methods/procedures. However, it is also strongly recommended that “triggers” be established that could indicate the need for a manufacturer to perform specific PMPF methods/procedures. 

Contact MedEnvoy about PMPF’s under the IVDR

If you have any additional questions regarding PMPF under the IVDR or require relevant training/consulting services, get in touch. 

Learn more about post-market performance follow-ups:

• What is the Difference Between PMS and PMPF Under the IVDR?