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

While post-market clinical follow-up (PMCF) studies were a concept established within the framework of the MDD/AIMDD, no corresponding concept of post-market performance follow-up (PMPF) studies were established under the IVDD. Subsequently, with the establishment of PMPF requirements in the IVDR, together with more robust post-market surveillance (PMS) requirements (as was the case for non-IVD medical device manufacturers under the MDR), manufacturers have at times struggled to understand the difference between PMS and PMPF under the IVDR. Here we discuss these concepts to help clarify the difference(s). 

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The Differences Between PMS and PMPF

Firstly, let’s begin with the definitions for each of these concepts under the IVDR, which are: 

• • Per Article 2(63): PMS means “…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.”
  •  Per Section 4, Part B, Annex XIV: PMPF “…shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part of this Annex and shall be specifically addressed in the manufacturer’s post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure,  with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ration and of detecting emerging risks on the basis of factual evidence.”

Additional Information on PMS and PMPF Under the Preamble to the IVDR

Furthermore, under the preamble to the IVDR, the following information is provided: 

 Post-market surveillance (PMS)

(31) “…manufacturers should have a…post-market surveillance system in place that is proportionate to the risk class and the type of device in question.”

(75) “Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation…To that end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance…should be used to update any relevant part of technical documentation, such as those relating to risk assessment and performance evaluation, and should also serve the purposes of transparency.” 

Post-Market Performance Follow-Up (PMPF)

(32) “The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of…post-market performance follow-up.”

From the definitions and preamble, we can already note that both PMS and PMPF are proactive processes with PMS having a much broader purpose of “identifying any need to immediately apply any necessary corrective or preventive actions”. The types of actions taken within the framework of PMS are either proactive (preventive actions) or reactive (corrective actions). Corrective actions taken within the framework of PMS include those actions taken to comply with IVDR vigilance requirements, including the reporting of serious incidents, trend reporting and, field safety corrective actions (FSCA).

On the other hand, PMPF has three specific purposes (all targeted at the performance evaluation process) of: 

• • Confirming the safety, performance, and scientific validity throughout the expected lifetime of the device; 
  • Ensuring the continued acceptability of the benefit-risk ration; and 
  • Detecting emerging risks based on factual evidence (as well as previously unknown risks or limits to performance and contra-indications, and possible systematic misuse). 

The Differences Between the Types of Activities and Information Collected

Let’s next review the types of activities performed, and information collected, within the scope of PMS and PMPF, as described in the IVDR: 

Remembering that the objectives of PMS are much broader than PMPF, there is overlap between the types of activities performed and information collected between PMS and general PMPF methods/procedures. However, there is significantly less overlap with specific PMPF methods. 

Of the two processes, PMS is mandatory under the IVDR while it is permissible for manufacturers to appropriately justify not performing PMPF. Although, given the strong degree of overlap of the activities and information between PMS and general PMPF methods/procedures, it would appear challenging for manufacturers to appropriately justify not at least performing general PMPF methods/procedures given that the same type of information is gathered within the PMS process, albeit for a broader purpose. 

This brings us to an important point that we believe warrants mentioning. PMPF is much more than just PMPF studies, and we have observed many manufacturers misunderstanding the scope of PMPF in the preparation of their Technical Documentation Files. Particularly, regarding the justification for not performing PMPF, we’ve noted manufacturer’s only justifying why they believe that PMPF studies do not apply to their device(s) instead of justifying why general and specific PMPF methods/procedures are not applicable. 

In conclusion, PMPF methods/procedures can be considered components of PMS (to identify any need to immediately apply any necessary corrective or preventive actions in general) that also specifically update the performance evaluation for the three purposes indicated previously. And while there is less overlap between specific PMPF methods/procedures and PMS, it is possible that information generated using these methods/procedures may also fall within the scope of PMS information (e.g.  non-serious incidents and data on any undesirable side-effects identified in PMPF studies).  It is critical that manufacturers establish appropriate justification when determining that PMPF methods/procedures are not applicable to their device(s). 

Contact MedEnvoy About PMPF and PMS Under the IVDR

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